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# Newsroom

*	***Elritercept is a late-stage, potentially best-in-class activin inhibitor designed to treat anemia associated with certain hematologic cancers, including myelodysplastic syndromes and myelofibrosis***
*	***Takeda to receive exclusive global license in all territories outside of mainland China, Hong Kong and Macau***
*	***Transaction builds upon Takeda’s legacy in the treatment of hematologic cancers and advances company’s global oncology strategy***

**OSAKA, Japan and CAMBRIDGE, Massachusetts, December 3, 2024** – Takeda ([TSE:4502/NYSE:TAK](https://www.takeda.com/investors/overview/)) today announced that it has entered into an exclusive licensing agreement with Keros Therapeutics, Inc. (Nasdaq: KROS) to further develop, manufacture and commercialize elritercept worldwide outside of mainland China, Hong Kong and Macau. 

Elritercept is a late-stage investigational activin inhibitor designed to treat anemia associated with certain hematologic cancers, including myelodysplastic syndromes (MDS) and myelofibrosis (MF). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of elritercept for very low-, low- and intermediate-risk MDS. MDS and MF are characterized by inadequate blood cell production, often leading to severe anemia that significantly impacts patient health and quality of life. Elritercept targets activin A and B proteins, which are believed to play a crucial role in anemia-associated diseases. In early clinical studies, elritercept has shown promising clinical activity and a manageable safety profile in patients with very low-, low- and intermediate-risk MDS as a monotherapy and in patients with MF in combination with standard of care.

“Elritercept has the potential to make a meaningful difference for patients with blood cancers, one of our key areas of strategic focus,” said Teresa Bitetti, President of the Global Oncology Business Unit at Takeda. “The addition of elritercept further bolsters our oncology pipeline and introduces a potential future growth driver for Takeda. I am excited to further advance the pioneering work begun by the Keros Therapeutics team with the goal of delivering this potential treatment option to patients.” 

Elritercept is currently in two ongoing Phase 2 clinical trials; one in patients with very low-, low- or intermediate-risk MDS and one in patients with MF. The Phase 3 RENEW trial evaluating elritercept in adult patients with transfusion-dependent anemia with very low-, low- or intermediate-risk MDS will begin enrollment soon. Takeda plans to evaluate elritercept in these cancers across patient segments and lines of therapy.

“We are excited to partner with Takeda, whose global reach and expertise in oncology and hematology will help unlock elritercept’s potential for patients with MDS and MF,” said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer at Keros Therapeutics. “With a differentiated mechanism of action targeting a broad range of pathways in blood cell production, elritercept has shown promise for patients who have not responded to standard therapies. This collaboration will accelerate development of elritercept for patients in need and offer new insights into these complex hematologic conditions.”

Under the terms of the agreement, Takeda will receive an exclusive worldwide license to further develop, manufacture and commercialize elritercept in all indications and territories outside of mainland China, Hong Kong and Macau. Takeda will be responsible for all development, manufacturing and commercialization as of the effective date of the agreement. Takeda will provide Keros Therapeutics with an upfront payment of $200 million and potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales. The agreement is subject to customary closing conditions, including completion of antitrust reviews.

## About Myelodysplastic Syndromes (MDS)
Myelodysplastic syndromes (MDS) are a group of diverse blood cancers in which the bone marrow fails to produce enough healthy blood cells. MDS is among the most common hematologic malignancies, with approximately 20,000 new cases diagnosed annually in the United States.1 Most people with MDS experience anemia, or low red blood cell counts, which impacts quality of life and mortality.2 75% of people living with MDS have low-risk MDS, with a median survival of approximately three to 10 years.3,4 Many low-risk MDS patients require frequent red blood cell transfusions, which can increase over time and negatively impact quality of life.5 Despite advances, additional therapeutic options are needed to improve quality of life and anemia symptoms for patients with low-risk MDS, particularly those whose disease is ringed sideroblast-negative or who have a high transfusion need.

## About Myelofibrosis (MF)
Myelofibrosis (MF) is a rare and life-threatening blood cancer characterized by the buildup of scar tissue in the bone marrow, which impairs its ability to produce normal blood cells. In the United States, approximately 3,000 new cases of MF are diagnosed each year.6 Patients with MF often experience anemia, enlarged spleen and other symptoms that significantly affect their quality of life. Although standard treatments can reduce spleen size and improve symptoms, they may exacerbate anemia and lead to low platelet counts. 

## About Elritercept
Elritercept is an investigational, potentially best-in-class activin inhibitor, targeting both activin A and activin B proteins, which are believed to play a crucial role in anemia-associated diseases. Elritercept is currently in two ongoing Phase 2 clinical trials; one in patients with very low-, low- or intermediate-risk MDS and one in patients with MF. The Phase 3 RENEW trial evaluating elritercept in adult patients with transfusion-dependent anemia with very low-, low- or intermediate-risk MDS will begin enrollment soon. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of elritercept for this condition. 

## About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [www.takeda.com](https://www.takeda.com/).

### Media Contacts:

#### Japanese Media

Tsuyoshi Tada

[tsuyoshi.tada@takeda.com](mailto:tsuyoshi.tada@takeda.com)

#### U.S. and International Media

Jennifer Anderson

[jennifer.anderson@takeda.com](mailto:jennifer.anderson@takeda.com)

## Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Forward-Looking Statements 
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: [https://www.takeda.com/investors/sec-filings-and-security-reports/](https://www.takeda.com/investors/sec-filings-and-security-reports/) or at [www.sec.gov](https://www.sec.gov). Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

## Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

## References: 
1.	Gorak E, et al. Discordant pathologic diagnoses of myelodysplastic neoplasms and their implications for registries and therapies. Blood Adv. 2023 Oct 24;7(20):6120-6129. doi: 10.1182/bloodadvances.2023010061.
2.	Haring Y, et al. MDS-Related Anemia Is Associated with Impaired Quality of Life but Improvement Is Not Always Achieved by Increased Hemoglobin Level. J Clin Med. 2023 Sep 9;12(18):5865. doi: 10.3390/jcm12185865.
3.	de Witte T, et al. Novel dynamic outcome indicators and clinical endpoints in myelodysplastic syndrome: The European LeukemiaNet MDS Registry and MDS-RIGHT project perspective. Haematologica. 2020 Nov 1;105(11):2516-2523. doi: 10.3324/haematol.2020.266817.
4.	Sekeres M, et al. Diagnosis and Treatment of Myelodysplastic Syndromes: A Review. JAMA. 2022 Sep 6;328(9):872-880. doi: 10.1001/jama.2022.14578.
5.	Wood E, et al. Outpatient transfusions for myelodysplastic syndromes. Hematology Am Soc Hematol Educ Program. 2020 Dec 4;2020(1):167-174. doi: 10.1182/hematology.2020000103.
6.	Mehta J, et al. Epidemiology of myeloproliferative neoplasms in the United States. Leuk Lymphoma. 2014 Mar;55(3):595-600. doi: 10.3109/10428194.2013.813500. Epub 2013 Jul 29.

Takeda to secure rights to elritercept, a treatment for anemia in hematologic cancers, enhancing their oncology pipeline.

Takeda Strengthens Oncology Pipeline with Elritercept through Licensing Agreement with Keros Therapeutics

Discover Takeda's research findings at ASH 2024, highlighting treatments for leukemia, lymphoma, and rare blood disorders.

Takeda to Showcase Latest Research at the 66th American Society of Hematology (ASH) Annual Meeting

* ***Approval Based on Results from Positive, Global, Phase 3 FRESCO-2 Trial***
* ***FRUZAQLA (fruquintinib) is the First Novel Targeted Therapy in Japan for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status in Over a Decade***

**OSAKA, Japan and CAMBRIDGE, Massachusetts, September 24, 2024** – Takeda [(TSE:4502/NYSE:TAK)](https://www.takeda.com/investors/overview/) today announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (generic name: fruquintinib), a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, for the treatment of advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy.

The approval is based primarily on the results of the FRESCO-2 trial, a global Phase 3 clinical trial conducted in the United States, Europe, Japan and Australia. The trial compared FRUZAQLA plus best supportive care (BSC) with placebo plus BSC in patients with previously treated metastatic colorectal cancer (mCRC). The FRESCO-2 trial met all primary and key secondary efficacy endpoints and demonstrated consistent benefits in patients who received FRUZAQLA, regardless of the types of therapy the patients had previously received. FRUZAQLA demonstrated a manageable safety profile in the FRESCO-2 trial, with the incidence of adverse events leading to discontinuation being 21% in the placebo plus BSC arm compared to 20% in the FRUZAQLA plus BSC arm.1 The data from the FRESCO-2 trial were [published](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00772-9/abstract) in *The Lancet* in June 2023.

Dr. Takayuki Yoshino, deputy director of hospital, head, Division for the Promotion of Drug and Diagnostic Development, and chief, Department of Gastrointestinal Oncology at the National Cancer Center Hospital East, who served on the FRESCO-2 study Steering Committee, said, “Although the mortality rate of colorectal cancer has been going down in recent years due to early screening and advances in treatment, the 5-year survival rate for metastatic colorectal cancer remains low and new treatment options are much in need. The approval of FRUZAQLA in Japan offers new hope for patients and families of patients with metastatic colorectal cancer, as well as for healthcare personnel involved in colorectal cancer treatment. I feel that it is of great clinical significance.”

“For more than a decade, Takeda has been a leader in advancing the treatment of metastatic colorectal cancer in Japan. With this approval of FRUZAQLA, we are able to further support patients living with this debilitating disease,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “FRUZAQLA is now approved in the U.S., European Union, Japan and a number of other countries around the world, and we remain committed to bringing this treatment to additional patients with metastatic colorectal cancer around the world who urgently need new therapeutic options.”

## About FRUZAQLA (fruquintinib)

FRUZAQLA is a selective oral inhibitor of all three VEGF receptors (-1, -2 and -3). VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. FRUZAQLA was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure achieving sustained target inhibition and flexibility for potential use as part of combination therapy.

Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. FRUZAQLA was approved by the U.S. Food and Drug Administration (FDA) in November 2023 and by the European Commission (EC) in June 2024. Fruquintinib is developed and marketed in China by HUTCHMED. Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE®.

### JAPAN IMPORTANT SAFETY INFORMATION

Please consult the FRUZAQLA (fruquintinib) Japan package insert (J-PI) before prescribing.

**WARNING:** FRUZAQLA should be administered only to patients for whom the use of FRUZAQLA is considered appropriate under the supervision of a physician with sufficient knowledge of and experience in cancer chemotherapy at a medical institution where adequate emergency care can be provided. Prior to treatment initiation, the efficacy and risks should be fully explained to the patient and/or his/her family and informed consent should be obtained; Severe gastrointestinal hemorrhage, including fatal cases, has been reported. Patients should be carefully monitored, and if any abnormalities are observed, administration of FRUZAQLA should be withheld and appropriate measures should be taken. If severe hemorrhage occurs, FRUZAQLA should not be re-administered; Gastrointestinal perforation has been reported with some fatal cases. Patients should be carefully monitored, and if any abnormalities are observed, administration of FRUZAQLA should be withheld and appropriate measures should be taken. If gastrointestinal perforation occurs, FRUZAQLA should not be re-administered.

**CONTRAINDICATIONS:** Patients with a history of hypersensitivity to any of the ingredients of FRUZAQLA.

**IMPORTANT PRECAUTIONS:** Hypertension, including hypertensive crisis, may occur. Blood pressure should be measured prior to the initiation of FRUZAQLA treatment and periodically during this treatment; Proteinuria may occur. Urinary protein should be monitored prior to the initiation of FRUZAQLA treatment and periodically during this treatment; If a surgical procedure is to be performed, patients are recommended to withhold FRUZAQLA before the surgery because wound healing may be delayed. Treatment resumption after the surgical procedure should be determined depending on the patient's condition upon confirmation of adequate wound healing.

**PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS:** **Patients with hypertension:** Hypertension may worsen; **Patients with bleeding diathesis or abnormal coagulation system:** Hemorrhagic events may occur; **Patients with hemorrhage such as gastrointestinal hemorrhage:** Hemorrhage may be enhanced; **Patients with a complication of intra-abdominal inflammation in the gastrointestinal tract, etc.:** Gastrointestinal perforation may occur; **Patients with current or a history of thromboembolism:** Transient ischaemic attack, thrombotic microangiopathy, pulmonary embolism, portal vein thrombosis, deep vein thrombosis, etc. may occur; **Patients with severe hepatic impairment (Child-Pugh Class C):** Since FRUZAQLA is metabolized mainly in the liver, blood concentrations may be increased. There have been no clinical studies conducted in patients with severe hepatic impairment; **Patients with Reproductive Potential:** Women of childbearing potential should be advised to use adequate contraception during treatment with FRUZAQLA and for 2 weeks after the last dose; **Pregnant Women:** FRUZAQLA can be administered to women who are or may be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with this treatment. In a rat embryo-fetal toxicity study, fetal abnormalities and teratogenic effects consisting of fetal external, visceral, and skeletal malformations and visceral and skeletal variations were observed at exposure levels approximately 0.05 times the exposure level (AUC) of FRUZAQLA at the maximum clinical dose (5 mg/day); **Breast-feeding Women:** It is advisable not to breastfeed. FRUZAQLA may pass into breast milk, and infants may experience serious adverse reactions if they are ingested through breast milk; **Pediatric Use:** There have been no clinical studies conducted in pediatric patients.

### ADVERSE REACTIONS:

Any of the adverse reactions listed below may occur. Patients should be closely monitored, and if any such abnormalities are observed, appropriate measures should be taken, including treatment discontinuation. Clinically Significant Adverse Reactions are follows.

**Hypertension:** Hypertension or hypertensive crisis may occur. If an increase in blood pressure is observed, appropriate treatment such as antihypertensive drug administration should be given as necessary, and if necessary, the dose of fruquintinib should be reduced, or fruquintinib administration should be interrupted. If severe or persistent hypertension, or hypertension that cannot be controlled by routine antihypertensive therapy occurs or if a hypertensive crisis occurs, fruquintinib administration should be discontinued; **Skin disorder:** Skin disorder including palmar-plantar erythrodysesthesia syndrome and rash may occur; **Hemorrhage:** Hemorrhage including epistaxis, hematuria, gastrointestinal hemorrhage and hemoptysis may occur. Fatal outcomes have been reported; **Gastrointestinal perforation:** Fatal outcomes have been reported; **Arterial thromboembolic events:** Arterial thromboembolic events including transient ischemic attack and thrombotic microangiopathy may occur; **Venous thromboembolism events:** Venous thromboembolism such as pulmonary embolism, portal vein thrombosis, and deep vein thrombosis may occur; **Posterior reversible encephalopathy syndrome:** If headaches, convulsions, lethargy, confusion, changes in mental function, blindness or other visual disturbances, or neurological impairment are observed, fruquintinib administration should be discontinued, and appropriate measures should be taken, including blood pressure control; **Arterial dissection:** Arterial dissection including aortic dissection may occur.

***For US Prescribing Information:*** https://www.fruzaqla.com/sites/default/files/resources/fruzaqla-prescribing-information.pdf

***For European Union Summary of Product Characteristics:*** https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla


## About the Phase 3 FRESCO-2 Trial

The FRESCO-2 study is a multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating FRUZAQLA plus BSC vs placebo plus BSC in patients with previously treated mCRC ([NCT04322539](https://clinicaltrials.gov/study/NCT04322539)). The study met all of its primary and key secondary endpoints, demonstrating that treatment with FRUZAQLA resulted in statistically significant and clinically meaningful improvement in overall survival and progression-free survival. The safety profile of FRUZAQLA in FRESCO-2 was consistent with previously reported fruquintinib monotherapy studies. Results from the study were [presented](https://oncologypro.esmo.org/meeting-resources/esmo-congress-2022/fresco-2-a-global-phase-iii-multiregional-clinical-trial-mrct-evaluating-the-efficacy-and-safety-of-fruquintinib-in-patients-with-refractory-met) at ESMO in September 2022 and subsequently [published](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00772-9/abstract) in *The Lancet* in June 2023.2,1

## Takeda’s Commitment to Colorectal Cancer in Japan

CRC is the most prevalent type of cancer in Japan, with an estimated 161,000 new cases and 54,000 deaths in 2023, according to the National Cancer Center’s statistics.3 While early-stage CRC can be surgically resected, mCRC remains an area of high unmet need with patients awaiting new treatment options, given its poor prognosis and limited treatment options.4-8 For over a decade, we have contributed to the treatment of patients with late-stage CRC who have limited treatment options and to the advancement of personalized treatment through the provision of innovative medicines and the generation of relevant evidence. Moving forward, we will continue our work to treat patients with CRC and address their unmet needs.

## About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

### Media Contacts:

#### Japanese Media

Akiko Manome

[akiko.manome@takeda.com](mailto:akiko.manome@takeda.com)

#### U.S. and International Media

Emma Nash

[emma.nash@takeda.com](mailto:emma.nash@takeda.com)

## Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: [https://www.takeda.com/investors/sec-filings-and-security-reports/](https://www.takeda.com/investors/sec-filings-and-security-reports/) or at [www.sec.gov](https://www.sec.gov/). Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

## Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

## References: 

1. Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023;402(10395):41-53. doi:10.1016/S0140-6736(23)00772-9.
2. Dasari NA, et al. LBA25 – FRESCO-2: A global phase 3 multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann Oncol. 2022 Sep;33(suppl_7): S808-S869. Doi:10.1016/annonc/annonc1089.
3. Foundation for Promotion of Cancer Research. Cancer Statistics In Japan. Tokyo, Foundation for Promotion of Cancer Research; 2023.
4. Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol 2023; 20(5)306-322. doi:10.1038/s41575-022-00736-1.
5. D'Haene N, et al. Clinical application of targeted next-generation sequencing for colorectal cancer patients: a multicentric Belgian experience. Oncotarget. 2018;9(29):20761-20768. Published 2018 Apr 17. doi:10.18632/oncotarget.25099.
6. Venderbosch, et al. Mismatch repair status and braf mutation status in metastatic colorectal cancer patients: A pooled analysis of the Cairo, Cairo2, coin, and Focus Studies. Clinical Cancer Res.,2014; 20(20):5322–5330. doi:10.1158/1078-0432.ccr-14-0332.
7. Koopman, M., et al. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. Br J Cancer. 209;100(2), 266–273. doi:10.1038/sj.bjc.6604867.
8. Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and Winding Road From Negative Predictive Factor to Positive Actionable Target.Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_351354.

Takeda announces the approval of FRUZAQLA (fruquintinib) by Japan's Ministry of Health, Labour and Welfare for the treatment of unresectable advanced or recurrent colorectal cancer. The approval is based on the successful Phase 3 FRESCO-2 trial.

Takeda Receives Approval for FRUZAQLA (fruquintinib) in Japan for the Treatment of Unresectable Advanced or Recurrent Colorectal Cancer

Takeda secures European Commission approval for FRUZAQLA (fruquintinib), a novel targeted therapy for previously treated metastatic colorectal cancer. Learn about the Phase 3 FRESCO-2 trial results. 

Takeda Receives Approval from European Commission for FRUZAQLA in Previously Treated Metastatic Colorectal Cancer

## News Releases



Divider Section

**Author: Awny Farajallah, M.D., Chief Medical Officer, Global Oncology Business Unit**

Over the past several decades, the rapid pace of scientific advancement has catalyzed a revolution in the way we treat cancers. This has led to a stronger focus on survival outcomes, and, in some cancers, many patients are living longer on treatment than ever before thanks to therapeutic developments such as novel targeted therapies and immunotherapy. The improvement in survival rates has created an opportunity – and obligation – to consider factors beyond just survival rates when it comes to the management of the disease.

As we continue to advance treatment options, there has been a growing movement towards prioritizing patient-centered care – considering the individual health status, preferences, values, and goals of patients when making treatment decisions. Balancing clinical outcomes with the real-world experiences of patients can be complex but is necessary to provide the best possible care. 

## Redefining Survival: The Dramatic Impact of Targeted Therapy

Let’s dive a little deeper into one of the reasons we’ve observed such notable improvements in the survival rates for certain cancer types – targeted therapies. Targeted therapies have revolutionized the way some cancers are treated by enabling us to target a genetic mutation that may be driving the cancer. This scientific achievement has dramatically changed the prognosis for certain types of cancers, such as breast and lung.

For example, breast cancer is the second-most common and lethal cancer type in women, and treatment options were previously limited to chemotherapies, radiation, and surgical procedures. For HER2-positive breast cancers specifically, which account for about 20% of all breast cancers, the disease is more aggressive and has a worse prognosis. The development of HER2-targeted drugs has forever changed the treatment approach and patient outcomes. In fact, some treatment combinations for this cancer extend survival to more than 4.5 years, compared to a life expectancy of 1.5 years achieved 14 years ago.1

A similar transformation has occurred in the treatment of non-small cell lung cancer (NSCLC), another widespread cancer that has been historically difficult to treat and was previously treated with chemotherapy, radiotherapy or a combination of both. Over time, we’ve learned that about 70% of patients with NSCLC have a targetable mutation, such as EGFR, BRAF, ALK or KRAS. With improved diagnostic testing, these patients are being matched with treatments that target their cancer at its source. As a result, in recent years, population-level mortality from NSCLC has fallen sharply.2

In addition to longer survival durations, some targeted therapies have also improved upon the toxicity profiles and administration of standard chemotherapies. For example, in a study comparing neoadjuvant targeted therapy versus neoadjuvant chemotherapy in advanced-stage EGFR-mutant NSCLC, the incidence of grade 3/4 adverse events was found to be significantly less in the targeted therapy group compared to the chemotherapy group.3 Many of these targeted therapies are administered orally, providing a more convenient dosing regimen for patients.4-10 

In the 20+ years since the first targeted therapies for cancer were introduced, they have revolutionized the diagnosis and treatment of patients with breast cancer, lung cancer and many other types of cancer, and made the possibility of extending patients’ lives while improving convenience, adherence and safety, a reality.11 

## From Survival to Survivorship 

While the rise in survival rates is an incredible accomplishment that will continue to be built upon as science advances, it has also brought about a paradigm shift in cancer care. With more cancer survivors living longer and more therapeutic options than ever before, there is greater impetus to evolve how we evaluate factors to identify the best treatment for each patient. 

For example, quality of life (QoL) and method of treatment administration are important real-world factors that should be considered in addition to clinical outcomes, as they play a crucial role in the everyday lives and experiences of patients. 

That said, how they are viewed and prioritized can differ by patient. For example, some patients may prioritize convenience and flexibility in treatment administration, while others may be more concerned about potential side effects or the impact of treatment on their ability to work or socialize. Some patients may prefer oral therapies that can be taken at home, while others may be comfortable with intravenous therapies administered in a clinical setting.

Evaluating these factors alongside traditional clinical standards when determining the best possible treatment ensures we are taking not only a patient’s survival into account – but also their quality of survivorship. Survivorship, in the context of cancer, refers to the journey and life experiences patients must navigate following their cancer diagnosis. Despite advancements in care over the past decade, there are still substantial gaps and challenges that need to be addressed to alleviate the short- and long-term effects of treatments – such as fatigue, cognitive problems, and pain – and their impact on an individual’s survivorship and long-term disease management. 

Because real-world factors and their role in survivorship are often not measured in randomized clinical trials, it’s crucial we invest in real-world evidence research and partner with patients and advocacy groups to understand how patients experience and prioritize factors such as location, family type, socioeconomic status, mental health, support systems, and cultural background and how these considerations influence their decisions.

Ultimately, the goal is to provide patients with the best possible opportunity of achieving long-term survival while also maintaining a good quality of life. This requires a collaborative effort between patients, their healthcare providers, and the healthcare industry to ensure that the unique needs and preferences of each patient are considered to improve care. 

## Looking Ahead

While clinical outcomes will continue to be paramount, as treatment options improve, it is imperative that additional factors are considered, and patients are actively involved in the decision-making process. Considering patient preferences on factors like quality of life, treatment feasibility and emotional well-being alongside considerations on clinical efficacy can help optimize outcomes and patient experience. 

By prioritizing an environment of trust, shared decision-making, and open communication, we can empower individuals to actively participate in their treatment journeys and become informed partners in their own care, which has been shown to improve their perception of quality of care and conversations with physicians.12

The future of cancer treatment lies in embracing an approach that considers a complete picture of patient health, recognizing not only survival as a key outcome but also incorporating the patient's overall well-being, or survivorship. By integrating real-world factors into treatment decision-making, prioritizing patient-centered care, and fostering ongoing research, we can collectively transform the cancer survivorship landscape and, hopefully, empower individuals worldwide to lead fulfilling lives beyond their diagnosis.

## References

1. Mendes D, Alves C, Afonso N, et al. The benefit of HER2-targeted therapies on overall survival of patients with metastatic HER2-positive breast cancer – a systematic review. Breast Cancer Res 17, 140 (2015). https://doi.org/10.1186/s13058-015-0648-2
2. Howlader H, Forjaz G, Mooradian M, et al. The Effect of Advances in Lung-Cancer Treatment on Population Mortality. N Engl J Med 2020;383:640-649. Published 2020 Aug 12. DOI: 10.1056/NEJMoa1916623
3. Chen D, Jin Z, Zhang J, et al. Efficacy and Safety of Neoadjuvant Targeted Therapy vs. Neoadjuvant Chemotherapy for Stage IIIA EGFR-Mutant Non-small Cell Lung Cancer: A Systematic Review and Meta-Analysis. Front Surg. 2021;8:715318. Published 2021 Aug 19. doi:10.3389/fsurg.2021.715318
4. Assoun S, Lemiale V, Azoulay E. Molecular targeted therapy-related life-threatening toxicity in patients with malignancies. A systematic review of published cases. Intensive Care Med. 2019;45(7):988-997. doi:10.1007/s00134-019-05650-w
5. Atrium Health. Treating Stage IV Lung Cancer With a Pill. Available at: https://atriumhealth.org/dailydose/2018/01/10/treating-stage-iv-lung-cancer-with-a-pill
6. XALKORI Prescribing Information. Pfizer. Available at: https://labeling.pfizer.com/ShowLabeling.aspx?id=676
7. ZYKADIA Prescribing Information. Novartis. Available at: https://www.novartis.com/us-en/sites/novartis_us/files/zykadia.pdf
8. ALECENSA Prescribing Information. Genentech. Available at: https://www.gene.com/download/pdf/alecensa_prescribing.pdf
9. LORBRENA Prescribing Information. Pfizer. Available at: https://labeling.pfizer.com/ShowLabeling.aspx?id=11140
10. ALUNBRIG Prescribinig Information. Takeda. Available at: https://www.alunbrig.com/sites/default/files/2022-10/prescribing-information.pdf
11. American Cancer Society. History of Cancer Treatments: Targeted Therapy. Available at: https://www.cancer.org/cancer/understanding-cancer/history-of-cancer/cancer-treatment-targeted-therapy.html
12. Kehl KL, Landrum MB, Arora NK, et al. Association of Actual and Preferred Decision Roles With Patient-Reported Quality of Care: Shared Decision Making in Cancer Care. JAMA Oncol. 2015;1(1):50–58. doi:10.1001/jamaoncol.2014.112

Over the past several decades, the rapid pace of scientific advancement has catalyzed a revolution in the way we treat cancers. Takeda Oncology │ Leadership │ Article

Living is More Than Surviving: Balancing Clinical Outcomes with Patient Impact

In the United States, colorectal cancer (CRC) is the third leading cause of cancer-related deaths, with a projected toll of over 50,000 deaths in 2024. Overall, the lifetime risk of developing CRC is about 1 in 23 for men and 1 in 25 for women.1

When people are diagnosed with later stage or more advanced CRC, it is known as metastatic CRC (mCRC).2 When a cancer metastasizes, it means that cancer cells have spread to other parts of the body.3 When caught early, CRC is often treatable and, in many cases, curable, speaking to the importance of screening and early detection. However, at least 20% of people are diagnosed with CRC in the metastatic stage, and about 50% of people diagnosed with localized CRC will develop metastases over the course of their disease.4,5 After cancer metastasizes, treatment can become much more challenging and as a result, many people experience diminished survival outcomes and quality of life.6

## A Prevalent Cancer, A Lack of Support

While CRC ranks among the most prevalent types of cancers, there are still considerable gaps in care and resources for patients, particularly for those experiencing structural challenges and barriers that impact both treatment access and survival outcomes.

The distribution of CRC and mCRC is not even across U.S. subpopulations; there is a marked difference in incidence among different racial and ethnic groups. For example, Black Americans are about 20% more likely to get CRC and about 40% more likely to die from it than any other racial group in the U.S.7 Additional factors that could impact disease experience with CRC are socioeconomic status, insurance access, geography and environmental exposure, among others.

> There is a wealth of information available around screening and prevention of CRC, but educational resources are sparse by comparison for patients with advanced CRC. While early detection of CRC is the hope, the unfortunate truth is that many people are either diagnosed with advanced CRC or will progress to it over time. Recognizing the challenges and diverse experience of those with mCRC is not widely documented. There is a critical need to develop comprehensive resources to assist the broader community in providing better support, particularly as new treatment options and combinations emerge, offering people more decisions to navigate.
>
> **ASHLEY CALABRESE**
> Associate Director, Policy and Advocacy, US Public Affairs

## A United Purpose to Support Advanced CRC Patients

Joined by a passion to make a difference for advanced CRC patients, Takeda and four leading advocacy organizations are launching a U.S. survey to identify the most pressing needs concerning disease and treatment navigation. Through this collaborative effort, we intend to uncover actionable insights that will help guide the collective development of resources and education to support patients. Our partners include:

**Colorectal Cancer Alliance:** Founded 25 years ago by more than 40 CRC survivors, caregivers and friends, the Alliance advocates for screening, magnifies patient support and accelerates research. It exists to end CRC in our lifetime.

**COLONTOWN:** Founded by a CRC survivor looking to create a disease-specific community, COLONTOWN empowers proactive colorectal cancer patients and caregivers with educational tools and relevant peer-to-peer support.

**BLKHLTH:** BLKHLTH is an Atlanta-based non-profit with a mission to advance the health of Black communities through equity-centered education, advocacy, research and programs.

**Family Reach:** Family Reach is a non-profit that provides non-medical financial support to people facing cancer. They work with patients, providers and community organizations to challenge the systems that force families to choose between their health and their home.

We will be unveiling findings for the survey throughout 2024. To learn more about our partners we are collaborating with, please visit their channels: [Colorectal Cancer Alliance](https://colorectalcancer.org/), [COLONTOWN](https://colontown.org/), [BLKHLTH](https://www.blkhlth.com/) and [Family Reach](https://familyreach.org/).

## References

1. American Cancer Society. Key Statistics for Colorectal Cancer. Available at: <https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html>

2. Memorial Sloan Kettering Cancer Center. Treatment for Metastatic Colon Cancer. Available at: <https://www.mskcc.org/cancer-care/types/colon/treatment/metastases>

3. City of Hope Cancer Treatment Centers. Metastatic Colorectal Cancer (stage 4). Available at: <https://www.cancercenter.com/cancer-types/colorectal-cancer/types/metastatic-colorectal-cancer>

4. Biller LH, Schrag D. Diagnosis and Treatment of Metastatic Colorectal Cancer: A Review. JAMA. 2021;325(7):669-685. doi:10.1001/jama.2021.0106

5. Atreya CE, Yaeger R, Chu E. Systemic therapy for metastatic colorectal cancer: from current standards to future molecular targeted approaches. Am Soc Clin Oncol Educ Book. 2017;37:246-256. doi:10.1200/EDBK_175679

6. American Cancer Society. Treatment of colon cancer, by stage. Available at: <https://www.cancer.org/cancer/types/colon-rectal-cancer/treating/by-stage-colon.html>

7. American Cancer Society. Colorectal Cancer Rates Higher in African Americans, Rising in Younger People. Available at: <https://www.cancer.org/cancer/latest-news/colorectal-cancer-rates-higher-in-african-americans-rising-in-younger-people.html>

Beyond early detection, how do we bridge the gap in metastatic colorectal cancer care. Learn about Takeda’s partnerships for patient support.

Beyond Early Detection: Bridging the Gaps in Metastatic Colorectal Cancer Support

Technological advances continue to push the boundaries of what's possible. Takeda's Teresa Bitetti discusses how we are leveraging these tools for cancer patients.


 Embracing AI & Emerging Technologies to Advance Cancer Care

**Author: Teresa Bitetti, President, Global Oncology Business Unit**

Many of us have loved ones who have been affected by cancer and understand the immense difficulty of processing a diagnosis and beginning treatment, both for the patient and their support network. Through personal and professional conversations with patients, we also recognize that their challenges often extend far beyond the initial diagnosis.

From financial and job insecurity, to depression and anxiety, to caregiving responsibilities – cancer treatment can be all-consuming. And while developing innovative medicines to treat cancer is at the heart of what we do as a pharmaceutical company, there is a lesser-known part as critical as the medicine – treating the whole patient. It’s this care beyond medicine where we have devoted more support in recent years.

## Mental Health and Well-Being

A cancer diagnosis can take an incredible toll on mental and emotional health, and recognizing changes in mood and behavior are critical during the journey according to the [American Cancer Society](https://www.cancer.org/cancer/managing-cancer/side-effects/emotional-mood-changes.html). Approximately 35% of patients diagnosed with cancer are impacted by a psychiatric disorder, and another 20% experience clinically relevant distressing psychosocial conditions such as demoralization and health anxiety.1 Research has shown that cancer patients receiving mental health support have better outcomes.2 Unfortunately, while mental health support may be a key part of a patient’s treatment journey, it is not always incorporated.3

Fortunately, there are several ways patients can be supported as they navigate the physical and emotional aspects of cancer. I am impressed by the resources that many of our partner patient advocacy organizations such as [CancerCare](https://www.cancercare.org/) provide – including emotional, practical and financial support – to navigate resources and the underlying emotions associated with diagnosis and treatment.

## Life Necessities and Obligations

A cancer diagnosis does not put life on pause. Patients may still need to feed themselves (and also family members), keep a roof over their heads, continue working, among many other aspects of life. Cancer is stressful enough without the added component of determining how to afford life.

Financial hardship impacts one in three patients diagnosed with cancer. And the risks disproportionality affect those who are socioeconomically disadvantaged and working-aged patients.4 The anxiety and stress of affording basic necessities can lead to poorer mental health, which can lead to poorer outcomes, perpetuating a vicious cycle. Fortunately, organizations such as [Family Reach](https://familyreach.org/) provide resources to help patients navigate non-medical expenses. No one should have to make the decision to put treatment on hold to keep food on their table or the lights on at home.

In addition, patients may also be caregivers – to children, to aging parents, to pets – a role that does not disappear at cancer diagnosis. Caregiving can be emotionally and physically taxing even without managing a cancer diagnosis and treatment. Organizations such as [Cancer Support Community](https://www.cancersupportcommunity.org/) offer resources to support dialogue between patient and those in their care as they navigate this journey together.

Cancer treatment is more than medicine. It’s the collaboration and commitment of many stakeholders to ensure that patients receive the care necessary to navigate their journey. At Takeda, I’m proud we partner with patient organizations around the globe – to raise awareness and provide support to help ensure the whole patient is being treated. This is the way we will truly reach our aspiration to cure cancer.

## References:

1. Caruso R, Breitbart W. Mental health care in oncology. Contemporary perspective on the psychosocial burden of cancer and evidence-based interventions. *Epidemiol Psychiatr Sci.* 2020;29:e86. doi:10.1017/S2045796019000866

2. Berchuck JE, Meyer CS, Zhang N, et al. Association of Mental Health Treatment With Outcomes for US Veterans Diagnosed With Non-Small Cell Lung Cancer. *JAMA Oncol.* 2020;6(7):1055-1062. doi:10.1001/jamaoncol.2020.1466

3. Oncology TL. Provision of mental health care for patients with cancer. *The Lancet Oncology*. 2021;22(9):1199. doi:10.1016/S1470-2045(21)00480-0

4. Smith GL, Lopez-Olivo MA, Advani PG, et al. Financial Burdens of Cancer Treatment: A Systematic Review of Risk Factors and Outcomes. *J Natl Compr Canc Netw.* 2019;17(10):1184-1192. doi:10.6004/jnccn.2019.7305

Hear from Teresa Bitetti, President of the Global Oncology Business Unit, as she discusses how Takeda and its partners are providing cancer care beyond medicine by supporting other areas of patients' lives, such as finances and mental health.

Cancer Treatment is More Than Medicine

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