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Newsroom

# Newsroom

Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. 

Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL

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

## News Releases



Divider Section

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**
> Patient Advocacy Lead, Colorectal Cancer, Takeda Oncology

## 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**

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

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## Media Materials

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