Takeda Oncology

# Decades of Leadership in Oncology



Takeda to Present Data at American Society of Hematology Annual Meeting, Demonstrating Commitment to Patients with Hematologic Diseases

Takeda to Present Data at 65th American Society of Hematology (ASH) Annual Meeting, Demonstrating Continued Commitment to Patients with Hematologic Diseases

Takeda announces the FDA has approved a new treatment for adults with previously treated metastatic Colorectal Cancer (mCRC)

Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

ADCETRIS receives EC approval for extension of marketing authorization in combination therapy for previously untreated Hodgkin lymphoma patients

European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD

**OSAKA, Japan and CAMBRIDGE, Massachusetts, October 2, 2023 **– Takeda ([TSE:4502/NYSE:TAK](https://www.takeda.com/investors/overview/)) today announced that, following discussions with the U.S. Food and Drug Administration (FDA), it will be working with the FDA towards a voluntary withdrawal of EXKIVITY®
(mobocertinib) in the U.S. for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-based chemotherapy. Takeda intends to similarly initiate voluntary withdrawal globally where EXKIVITY is approved and is working with regulators in other countries where it is currently available on next steps.

This decision was based on the outcome of the Phase 3 EXCLAIM-2 confirmatory trial, which did not meet its primary endpoint and thus did not fulfill the confirmatory data requirements of the [Accelerated Approval ](https://www.takedaoncology.com/news/news-releases/takedas-exkivity-mobocertinib-approved-by-us-fda-as-the-first-oral-therapy-specifically-designed-for-patients-with-egfr-exon20-insertion-nsclc/)granted by the U.S. FDA nor the conditional marketing approvals granted in other countries.

The EXCLAIM-2 trial was a Phase 3, multicenter, open-label study designed to investigate the safety and efficacy of EXKIVITY as a monotherapy versus platinum-based chemotherapy in first-line EGFR Exon20 insertion+ locally advanced or metastatic NSCLC. No new safety signals were observed in the EXCLAIM-2 trial. Full data from the trial will be presented at an upcoming medical meeting or published in a peer-reviewed journal.

“Our steadfast commitment to pursue solutions for people with high unmet needs led us to develop and launch EXKIVITY as the first oral therapy designed for patients with EGFR Exon20 insertion+ metastatic NSCLC,” said Awny Farajallah, MD, head of Global Medical Affairs Oncology at Takeda. “We have been fortunate to witness the impact EXKIVITY has had on this previously underserved population and are encouraged to see the advancements made since its approval to introduce new therapies for these patients. We hope that findings from the EXCLAIM-2 study will inform future research and development for this disease.”

Takeda is committed to ensuring patients receiving EXKIVITY can maintain access, as appropriate and in consultation with their healthcare provider. We are actively assessing access mechanisms with regulatory authorities. Patients currently being treated with EXKIVITY should consult their healthcare provider. For questions related to ongoing access, please contact us at <globaloncologymedinfo@takeda.com>.

Takeda will continue to assess the impact of the withdrawal and update our full-year, consolidated forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023), as appropriate and necessary.

## About EXKIVITY (mobocertinib)

EXKIVITY is a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. EXKIVITY was approved based on the results from the platinum-pretreated population in the Phase 1/2 trial of EXKIVITY in patients with EGFR Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (NSCLC). For more information about EXKIVITY in the U.S., healthcare professionals may visit [www.exkivity-update.com](http://www.exkivity-update.com). For the U.S. Prescribing Information, including the Boxed Warning, please visit [www.exkivity-update.com/prescribing-information](http://www.exkivity-update.com/prescribing-information).

## About EGFR Exon20 Insertion+ NSCLC

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 2.2 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.1-2 Patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) NSCLC make up approximately 1-2% of patients with NSCLC, and the disease is more common in Asian populations compared to Western populations.3-7 This mutation carries a worse prognosis than other EGFR mutations, as EGFR tyrosine kinase inhibitors (TKIs) – which do not specifically target EGFR Exon20 insertions – and chemotherapy provide limited benefit for these patients.

Takeda is committed to continuing research and development to meet the needs of the lung cancer community through the discovery and delivery of transformative medicines.

## 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 disease, plasma-derived therapies, neuroscience, oncology 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](http://www.takeda.com).

## Media Contacts:

### Japanese Media

Jun Saito

[jun.saito@takeda.com](mailto:jun.saito@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/> or at [www.sec.gov](http://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. Sung H. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. <https://pubmed.ncbi.nlm.nih.gov/33538338/>. Accessed September 20, 2023
2. American Cancer Society. What is Non-Small Cell Lung Cancer? <https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html>. Accessed September 20, 2023.
3. Riess, Jonathan W. Diverse EGFR Exon 20 Insertions and Co-Occurring Molecular Alterations Identified by Comprehensive Genomic Profiling of NSCLC. <https://www.jto.org/article/S1556-0864(18)30770-6/fulltext>. Accessed September 20, 2023.
4. Fang, Wenfeng. BMC Cancer. EGFR exon 20 insertion mutations and response to osimertinib in non-small-cell lung cancer. <https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-5820-0>. Accessed September 20, 2023.
5. Kobayashi Y, Mitsudomi T. Not all epidermal growth factor receptor mutations in lung cancer are created equal: Perspectives for individualized treatment strategy. Cancer Sci. 2016;107(9):1179-1186. doi:10.1111/cas.12996. Accessed September 20, 2023.
6. Yatabe Y, Kerr KM, Utomo A, et al. EGFR mutation testing practices within the Asia Pacific region: results of a multicenter diagnostic survey. J Thorac Oncol. 2015;10(3):438-445. doi:10.1097/JTO.0000000000000422. Accessed September 20, 2023.
7. Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014;311(19):1998-2006. doi:10.1001/jama.2014.3741. Accessed September 20, 2023.

Takeda will be working with the FDA towards a voluntary withdrawal of EXKIVITY (mobocertinib) in the U.S. and globally where it is currently available.

Takeda Provides Update on EXKIVITY® (mobocertinib)

## Oncology News



# Oncology Pipeline&#xA;

Discovering and developing innovative therapies to deliver potentially transformative treatments


Science

/science/

Medicines

/medicines/

Patients

/patients/

Investors

https://www.takeda.com/investors/

Partnerships

/partnerships/

Oncology Careers

/about/careers/

## About Takeda Oncology



# Divider Section

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

I recently had a conversation with a good friend of mine who is a colorectal cancer (CRC) survivor. It was a particularly poignant get together as this was the first time we had chatted at length since Takeda acquired the license for a promising treatment in CRC. As my friend shared with me her personal experience with cancer, we also discussed the challenges faced by many beyond their 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

Innovations in data, digital and technology continue to drive the latest advancements in oncology research, propelling us into the future of therapeutic development and identifying ways to more efficiently deliver new medicines to patients. As we learn to apply the tools provided by this field, we are offered the chance to discover and establish improved standards of care for people living with cancer. How can we use the latest technology to enhance our medicines and make a real difference in the lives of patients?

Listen to Takeda’s Christine Ward, Ph.D., Head of Oncology and Cell Therapy Precision & Translational Medicine, and Julie Dixon, Ph.D., Head of Global Regulatory Affairs, as they answer this question and reflect on how data, digital and technology is transforming their work and redefining possibilities for the next era of oncology.


Listen to Takeda’s Christine Ward, Ph.D., Head of Oncology and Cell Therapy Precision & Translational Medicine, and Julie Dixon, Ph.D., Head of Global Regulatory Affairs, as they answer this question and reflect on how data, digital and technology is transforming their work and redefining possibilities for the next era of oncology.

Embracing Innovation: How Today’s Tech is Transforming Translational Medicine for Patients with Cancer

Over the last decade, the multiple myeloma treatment landscape has rapidly evolved. While scientific innovation and the emergence of new therapies have helped provide a renewed sense of hope to people living with multiple myeloma, it has also made navigating the treatment journey more complex.

Given this, it is more critical than ever to ensure that we are stepping up to provide optimal education and support for patients, so they have access to the right resources and information based on their needs, concerns, desires and treatment goals. The way we can do this is by going directly to the source and hearing from patients.

At Takeda, we are focused on continuing to expand the programs that allow us to gather deep, unfiltered insights directly from patients and their care partners to better understand the needs of the myeloma community. In celebration of Myeloma Action Month, I wanted to shed light on one of Takeda Oncology’s trailblazing programs and how it has given us invaluable insights into the myeloma patient experience.

## The Patient Advocacy Liaisons

The Patient Advocacy Liaisons, or PALs, are a field-based team of myeloma experts whose mission is to deliver meaningful disease education to patients and their care partners with a focus on patient empowerment.

The program was established in 2021, and since then, the PALs have delivered more than 250 educational presentations to nearly 5,000 patients and care partners based directly on what we hear from patients – namely, the gaps in knowledge they have about their disease. These presentations take place in the support group setting or during patient organization events. These ~5,000 people have shared the information they learn within their own networks, creating a much larger reach. In the words of one of our patient leadership council members, “when you educate one patient, you educate thousands.”

PALs don’t just talk to people with myeloma, they talk *with* them, gathering information about their unmet needs. Following a presentation, PALs actively request feedback from attendees, and take those unfiltered insights and learnings into consideration when developing new educational content so it reflects the most timely and relevant educational needs facing patients today. PALs also co-create content with key opinion leaders including members of our Patient Leadership Council and expert patient advocates, ensuring it is easy to understand and optimized for the patient and care partner audience.

Our current PALs are Tara Roy MS, NP, AOCNP, and Rebekah Tobin, RN, BSN. Over the last year, they have delivered presentations aimed at helping patients understand their risk status, side effect management, lab values, cancer survivorship and wellness, infection risk, the importance of vaccinations and more. Our hope is that when patients are armed with this information, they can become stronger self-advocates and have a more-informed, ongoing dialogue with their care team, which can ultimately improve patient outcomes.

PAL Rebekah Tobin shared, “hearing the success stories post-program from people and care partners utilizing our PALs resources to help overcome their barriers is extremely rewarding. People living with myeloma and their care partners see that we take the feedback they provide and create presentations and resources which make them feel seen, heard, understood and valued. This aspect is incredibly important in distinguishing the PAL role from other advocacy roles in the industry.”

Our amazing partner organizations, like HealthTree and the International Myeloma Foundation, allow us to utilize their existing, well-established structures that provide patients and care partners with education and support to serve as forums for our programs. Patients can look out for upcoming events that the PALs will attend to deliver presentations through patient organization websites and social media channels.

Looking ahead, based on the feedback we have received, we plan to deliver presentations on strengthening communication with healthcare teams and focusing on mental health and resilience when navigating a myeloma diagnosis. We also ultimately hope to expand the PALs program into other disease areas.

“One of the most rewarding aspects as a PAL is knowing the positive impact made on patients and their caregivers as they gain the knowledge they need through our disease-based educational programs, take the information learned back to their healthcare team and feel empowered to take control of their care as they navigate through their cancer journey,” said PAL Tara Roy.


Over the last decade, the multiple myeloma treatment landscape has rapidly evolved. While scientific innovation and the emergence of new therapies have helped provide a renewed sense of hope to people living with multiple myeloma, it has also made navigating the treatment journey more complex.

Empowering Patients by Elevating Their Voices: The Patient Advocacy Liaisons Program

The decisions that a health care provider (HCP) makes immediately after a patient’s cancer diagnosis often define their treatment journey. For patients with lung cancer, one of those critical decisions is when and how to approach diagnostic testing to ensure any cancer-driving mutation(s) are properly identified. Having this information confirmed from the start allows HCPs to prescribe treatment(s) that specifically target their patient’s disease, giving them the best possible chance to optimize outcomes.1
Next-generation sequencing, or NGS, provides comprehensive testing – helping to optimize diagnosis and ensure HCPs consider all potential treatment options for their patients, including any targeted options that may be available. In rare lung cancers – like epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) non-small cell lung cancer (NSCLC) – NGS testing is a useful tool due to the distinct nature of the mutations.2
So why is this critical tool – one that has improved our understanding of cancer development and progression – not being utilized universally as standard of care?3
We gathered perspectives from several experts on what is preventing the universal adoption of NGS, and how these barriers need to be broken down to help HCPs make their care approach stronger and, ultimately, improve outcomes for patients.

## Lack of Awareness

It’s important to acknowledge that not all forms of testing are created equal. Due to the heterogeneity in length and positions of certain mutations, NGS is a more comprehensive option for detecting compared to polymerase chain reaction, or PCR, testing, which doesn’t have the same capabilities.2,4 For example, PCR testing is projected to capture about 50% of EGFR Exon20 insertion+ cases.5 Due to its limited ability to identify certain mutations, PCR tests may prevent patients from being prescribed appropriate treatments designed for their specific cancer, potentially preventing them from achieving their desired health outcomes.2,6
Wider adoption of NGS testing has enabled the identification of rare mutations that may be missed with commercially available tests, leading to a growing number of previously unidentified mutations. This has, in turn, facilitated the use of [precision medicine](https://www.fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine).7-8 Despite these benefits and capabilities to pinpoint a patient’s lung cancer, NGS testing continues to be underutilized in the clinical setting.9 According to a *JCO Precision Oncology* [study](https://ascopubs.org/doi/full/10.1200/PO.22.00246) that evaluated patients with newly diagnosed advanced NSCLC, approximately 64% of potentially eligible patients for precision oncology therapies appropriate for their lung cancer did not benefit from them due to factors associated with clinical gaps, including pre-analytic biomarker testing.9 Too few clinicians are aware of the potential impact of NGS testing, and broader awareness is needed to ensure lung cancer patients are able to benefit from it.9

## Logistical Concerns

One of the common concerns from those who *are* aware of NGS tests is that results take longer than PCR tests, thus pushing back the timeline for when patients can begin treatment.3
While time is of the essence when diagnosing a disease as serious as lung cancer, waiting for the results of the NGS test will ultimately benefit the patient.3,10 HCPs should look at this issue comprehensively and recognize that prescribing the wrong therapy can cause a negative ripple effect and impact several aspects of the patient’s journey.9 Prescribing the wrong treatment may result in the patient’s cancer progressing more quickly or acquiring resistance mutations that complicate treatment sequencing.9,11-12 When NGS testing is taken into consideration at the very beginning, HCPs can ensure that all potential diagnoses and treatment options are initially explored, facilitating a path for patients to receive an optimized diagnosis and timely treatment decisions.1,9

## Reimbursement

PCR tests are the more commonly used testing method because equipment to run them is more accessible and are generally perceived as more cost-effective.3,11 However, in recent years payers have grown increasingly receptive to reimbursing for NGS tests. There are several ways coverage can be achieved for NGS testing.13 Local coverage determination, in which a Medicare Administrative Contractor reviews a test performed in that jurisdiction.

* National coverage determination, which provides access to testing for all Medicare patients nationally.
* Through private payers, which each generate their own coverage policy. Coverage policies from payers can vary significantly and may address all NGS-based tests or just one specific diagnostic test.
* Through Medicaid, in which oncology and biomarker tests are paid for directly on a state-by-state basis through diagnostic companies or health insurance.
 The most influential factor on coverage and reimbursement decisions is the clinical evidence that supports the validity of the test. As the reimbursement outlook improves and more targeted therapies are approved, pathologists anticipate an increase in NGS-based testing moving forward.13

Using NGS testing provides patients with an optimized diagnosis and thus the opportunity to receive a treatment designed to target their disease at the molecular level.1 This is why Takeda partners with industry stakeholders and companies like Thermo Fisher Scientific and Foundation Medicine, in order to address the urgent need for broader access to genomic tests, ultimately expanding treatment options for patients. Takeda remains dedicated to supporting these efforts to expand the availability and accessibility of NGS testing so that more patients can benefit from and have access to life-transforming medicine.

*Takeda Oncology and Foundation Medicine are currently partnering on the development of Foundation Medicine’s tissue- and blood-based companion diagnostics, with the goal of improving outcomes for people with* [*anaplastic lymphoma kinase-positive (ALK+)*](https://www.foundationmedicine.com/press-releases/1f035abc-35f0-417f-bf06-2115eb386579) *and EGFR Exon20 insertion+ mNSCLC. To learn more about the* [*partnership*](https://www.foundationmedicine.com/press-releases/7c611e86-4d8a-452e-9f41-8fda9901af36) *or Foundation Medicine’s approach to genomic profiling, you can visit* [*https://www.foundationmedicine.com/*](https://www.foundationmedicine.com/)*.*

### References

1. Pennell N et al. *JCO Precision Oncology*. Economic Impact of Next-Generation Sequencing Versus Single-Gene Testing to Detect Genomic Alterations in Metastatic Non-Small-Cell Lung Cancer Using a Decision Analytic Model. 2019.
2. Viteri S, Minchom A, Bazhenova L, et al. \_Molecular Oncology.\_Frequency, underdiagnosis, and heterogeneity of epidermal growth factor receptor exon 20 insertion mutations using real-world genomic datasets. 2022;1:1-8
3. Berger et al. *Nat Rev Clin Oncol.* The emerging clinical relevance of genomics in cancer medicine. 2018; 15(6):353-365
4. Khoo C, et al. *Transl Lung Cancer Res*. Molecular methods for somatic mutation testing in lung adenocarcinoma: EGFR and beyond. 2015;4:126-141
5. Ou S, Hong J, Lin H, et al. *Journal of Thoracic Oncology.* Distribution and Detectability of EGFR Exon20 Insertion Variants in Non-Small Cell Lung Cancer. 2021;16:S928-S929
6. Lin HM et al. *Journal of Thoracic Oncology* EGFR Testing Patterns and Detection of EGFR Exon 20 Insertions in the United States. 2022;3.
7. Food and Drug Administration. Precision Medicine. 2018. <https://www.fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine>
8. Russo A, et al. *Oncotarget*. Heterogeneous Responses to Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors (TKIs) in Patients with Uncommon EGFR Mutations: New Insights and Future Perspectives in this Complex Clinical Scenario. 2015;6:26814-26825.
9. Sadik H, Pritchard D, Keeling DM, et al. *JCO Precision Oncology*. Impact of Clinical Practice Gaps on the Implementation of Personalized Medicine in Advanced Non–Small-Cell Lung Cancer.
 2022;6.
10. Cainao C et al. *Biology (Basel*). Next Generation Sequencing Technology in Lung Cancer Diagnosis. 2021; 10(9)
11. Schluckebier L, Caetano R, Garay OU, et al. National Library of Medicine. *BMC Cancer*. Cost-effectiveness analysis comparing companion diagnostic tests for EGFR, ALK, and ROS1 versus next-generation sequencing (NGS) in advanced adenocarcinoma lung cancer patients. 2020.
12. Pacini L et al. *Pharmcogenomics and Personalized Medicine*. Tackling Drug Resistance in EGFR Exon 20 Insertion Mutant Lung Cancer. 2021;14:1-17.
13. Ferrara et al. Pieran Dx. 2020 NGS Testing Reimbursement Overview Strategies for Clinical NGS Deck. 2019.

The decisions that a health care provider (HCP) makes immediately after a patient's cancer diagnosis often define their treatment journey.

Breaking Down Barriers Preventing the Use of NGS

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