Greetings from FDA Oncology!
Welcome to the October 2024 edition of the FDA Oncology Center of Excellence (OCE) quarterly newsletter from Project Community. This newsletter provides a summary of OCE's upcoming public events, educational opportunities, and recent oncology product approvals. These are free and everyone is welcome. Watch for updates throughout 2024 and send your suggestions to OCE-Engagement@fda.hhs.gov.
Center Director's Message
Hi Advocates,
OCE recently conducted a “Benchmarks for Diversity in Oncology Clinical Trials” joint symposium with the American Cancer Society. One important highlight you should know about is the draft guidance, “FDA Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” I believe there are three reasons Diversity Actions Plans (DAPs) are necessary, especially for cancer clinical trials:
- To promote social equity among people facing cancer.
- To drill down on extrinsic factors such as diet, cancer education and the work necessary to function within the constraints of health care systems.
- To foster better understanding of intrinsic ethnic and biological commonalities associated with ancestral origins.
OCE welcomes the expected drug development equity DAPs can potentially create for all patients facing cancer.
Early next year, OCE will launch Project Connect on World Cancer Day, February 4, 2025. Stay tuned for updates on the Conversation on Cancer public panel discussion dedicated to this focus on international cancer patient engagement.
The November 19, 2024 Conversation on Cancer, in conjunction with the European Medicines Agency (EMA) will examine an array of challenging decisions faced by members of the pediatric oncology community.
This fall marks my silver anniversary leading the oncology program at FDA. Register here to watch me chat with former FDA Commissioners during the “Pazdur+25” Conversation on Cancer on October 23!
Sincerely,
Richard Pazdur, MD • OCE Director
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Upcoming Events
Conversations on Cancer: Pazdur + 25 Years
Join previous FDA Commissioners and the FDA Oncology Center of Excellence in recognizing a quarter century of federal government service by OCE Center Director, Dr. Richard Pazdur. The esteemed panel will highlight the many oncology advances and changes at FDA throughout Dr. Pazdur’s tenure. The panel discussion takes place October 23, 2024, from 2 to 3 pm ET and will focus on Dr. Pazdur’s unceasing and continuing service to the global oncology community.
Conversations on Cancer Pediatric Cancers: Navigating the Challenges Together
Working or too busy to watch Conversations on Cancer? Catch up by viewing past events posted on the Conversations on Cancer web page!
ICYMI (In Case You Missed It)
Conversations on Cancer
September 20, 2024: Conversations on Cancer—National Hispanic/Latino Family Cancer Awareness Week. Watch on YouTube in English; en español; em português.
The FDA Oncology Center of Excellence Project Community held its inaugural National Hispanic/Latino Family Cancer Awareness Week September 20-26, 2024. A social media campaign was also conducted throughout the week, using the hashtag #LatinoCancer. The purpose was to increase cancer awareness in the Hispanic/Latino population. Despite advances in cancer prevention and precision cancer care, cancer is the leading cause of death for the Hispanic/Latino population in the US. The initiative aimed to gather community-based groups to increase cancer awareness and build knowledge surrounding cancer clinical trial participation as well as increasing understanding of ways to contribute to national genetic databases for cancer research.
Patients and Advocates at Recent Meetings
 Above: OCE Dep. Dir. Paul Kluetz, Former NFL Player Darryl Haley, OCE Center Director Rick Pazdur, Associate Director Rea Blakey and Deputy Director Marc Theoret take a quick break together at the White Oak campus.
 Above: An OCE audience “Meets the Press” during a recent chat at FDA with Ramsey Baghdadi, co-founder of Prevision Policy (third from left) and Kate Rawson, senior editor at Prevision Policy (fourth from left).
 FDA and OCE staff celebrate Dr. Richard Pazdur’s ongoing 25 years of service at the agency during an FDA Fall Tailgating event.
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OCE's Social Media Specialist
At right, the voice behind the camera on OCE social media videos such as this one with Associate Director Rea Blakey, communications specialist Marivon Sama, with her tripod and camera at the FDA White Oak campus recently.
You can find her work on OCE's X (formerly Twitter) account @FDAOncology and the FDA's LinkedIn and Facebook accounts!
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Getting to Know You!
In this issue we are pleased to highlight Ivory Allison, National Senior Director, Community Impact, at American Liver Foundation.
With liver cancer rates on the rise, particularly within diverse and often underserved communities, it has been rewarding to empower individuals, reduce stigma, and enhance liver health and overall well-being in these communities. Having a positive impact on people’s lives has been a joy. I have been with the American Liver Foundation for 14.5 years, serving in multiple positions and this has been my most fulfilling role yet with the organization.
Q: What are you currently working on that makes you feel excited or proud?
Working on collaborating with diverse organizations such as Blackdoctor.org, Association of Black Gastroenterologists and Hepatologists, Latinx Physicians of CA, National Coalition of 100 Black Women, Inc., PA Chapter, Balm in Gilead and Black Health Matters Summit to educate the community and patients on liver health and wellness in the Black community.
Our upcoming Liver Cancer Series is a 4-part webinar providing education and resources for communities including African Americans, Hispanics, and American Indians. These sessions will cover key factors including risks for and prevalence of liver cancer, cultural influences, and effective prevention and treatment strategies.
Q: What has your experience been working with the Oncology Center of Excellence, Project Community?
In recent years, we’ve participated in the National Black Family Cancer Awareness Week by enhancing our educational initiatives on Liver Cancer, particularly our social media campaign. This collaboration with the FDA Oncology Center of Excellence has been great and allowed us to connect the CDC’s Division of Viral Hepatitis and Cancer departments with the FDA’s Oncology Center. These valuable connections have enhanced our ability to increase awareness about liver cancer and to strengthen our outreach efforts. We look forward to future collaborations.
Q: Please share any advice you or your organization have for other advocates.
By regularly bringing together medical professionals, patient advocates, and community representatives from varied backgrounds who are knowledgeable about the challenges and barriers faced by diverse groups of people, you will enhance the inclusivity of your offerings and learn new and better strategies for reaching a wider range of individuals impacted by health disparities. I have learned how vital it is to educate people to be advocates for their health and that they are the leaders of their healthcare journey. Education is the first step in becoming an empowered advocate.
For more information on Liver Cancer and the American Liver Foundation, go to www.liverfoundation.org.
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Each newsletter will highlight a Project Community advocate we have had the privilege of engaging with. If you would like to nominate your organization, or for any additional information, please reach out to us at OCE-Engagement@fda.hhs.gov. Subject line: Newsletter Nomination for Getting to Know You.
Getting to Know OCE!
Dr. Bindu Kanapuru is a hematologist-oncologist who leads the OCE Cancer in Older Adults Program, dedicated to improving outcomes for older adults with cancer. She works with internal and external stakeholders and other OCE programs to provide direction and coordination of scientific and policy efforts related to cancer in older adults.
Dr. Kanapuru also is the supervisory associate director of therapeutic review in the FDA Division of Hematologic Malignancies II, a position she has held since 2023. In that role, she oversees the development of therapies for patients with lymphoma and multiple myeloma.
Prior to joining the FDA in 2015, Dr. Kanapuru was in private Hematology/Oncology practice in Virginia. She completed her fellowship in hematology and oncology at the University of Maryland Medical Center in Baltimore. During her fellowship, she pursued research at the National Institute on Aging on frailty and cancer, and anemia in the elderly. Dr. Kanapuru joined the FDA in 2015 as a clinical reviewer in the Division of Hematology Products, becoming a multiple myeloma team leader in 2019.
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Facts about FDA
True or False? There’s no better way to screen for breast cancer than mammography.
True! Learn more about mammograms here: Breast Cancer Screening: Thermogram No Substitute for Mammogram
Also, check out the FDA Rumor Control web page and share the facts, not the falsehoods. Fact sheets are available in English, Spanish, Korean, Chinese, Vietnamese, and Tagalog.
 September 25: osimertinib for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. This application was granted priority review and breakthrough designation.
September 20: isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for adults with multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).
September 19: amivantamab-vmjw with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
September 17: pembrolizumab with pemetrexed and platinum chemotherapy for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma.
September 17: ribociclib for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III breast cancer at high risk of recurrence. FDA also approved the ribociclib and letrozole co-pack for the same indication.
September 12: atezolizumab and hyaluronidase-tqjs for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS).
Learn more about how to use product labeling and browse or search the full list of FDA oncology approvals. You can also watch OCE’s Project Livin’ Label, an FDA-led conversation with a patient, an oncologist, a representative from the drug company, FDA oncologists, an oncology nurse, and an oncology pharmacist talking about the backstory of a recent oncology approval.
 November
- Lung Cancer Awareness Month
- National Family Caregiver Month
- Carcinoid Cancer Awareness Month
- Pancreatic Cancer Awareness Month
- Stomach Cancer Awareness Month
December
- San Antonio Breast Cancer Symposium, December 10–13, 2024.
- Aplastic Anemia Awareness Month
- Cancer-Related Fatigue Awareness Month
January
- Cervical Cancer Awareness Month
Brought to you by Project Community
Project Community is a public health outreach initiative established by the FDA Oncology Center of Excellence for patients living with cancer, survivors, advocates, families, and people living in underserved urban and rural communities who are at greater cancer risk. Our goal is to increase communication between the underserved and medical professionals in communities nationwide, to foster understanding, and awareness to reduce cancer risk and increase survival.
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