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Greetings from FDA Oncology!

Welcome to the January 2024 edition of the FDA Oncology Center of Excellence (OCE) quarterly newsletter from Project Community. This newsletter provides a summary of OCE upcoming free public events and educational opportunities, and recent oncology product approvals.

Director's Message

Happy New Year! At OCE we wrapped up another year of cancer drug development and are planning for even greater engagement this year. Many of you provided positive feedback on the Conversations on Cancer collaboration with the European Medicines Association in October. After serving as a panelist representing the metastatic breast cancer community in Europe, Jo Taylor wrote: “It was a really great event and I do hope it’s the start of actual action in helping patients to get better outcomes with MBC and having clinical trials interweaved into their treatment lines.” With your participation, we plan to build on this relationship with more internationally focused panel discussions and by developing an international patient advocacy project. Watch for updates and send suggestions to OCE-Engagement@fda.hhs.gov. Mark your calendars for Conversations on Cancer public panel discussions Jan. 10, Feb. 1 and 27. Registration links will be posted on @FDAOncology on X, @FDA on LinkedIn, and the OCE Meeting Calendar. Meeting with advocates at conferences like AACR and ASCO are a highlight for us. The Project Community team and I look forward to seeing many of you in 2024. Another highlight is seeing your creative participation in the National Black Family Cancer Awareness campaign. This year’s campaign will be held June 13-19. And, having heard from advocates for the Hispanic community, we’re adding a cancer awareness campaign during Hispanic Heritage Month in September. More to come! Sincerely, Richard Pazdur, MD • OCE Director

Upcoming Events

Conversations on Cancer: Bringing Innovation to People Facing Cancer

This public panel discussion will highlight oncology drug approvals in 2023. We will review a wide range of cancers, approval of novel drugs, and new uses for previously approved drugs.

Join us January 10, 2024, from 2 to 3 pm ET.

A diverse group of speakers including patients/advocates, clinical investigators and practitioners will discuss their experiences with these drugs.

ICYMI (In Case You Missed It)

Conversations on Cancer: How Biotech Built a Blockbuster Cancer Drug

This discussion November 30, 2023, examined the challenge of developing new treatments for cancer and what it takes to bring a new drug from research and development to patients with cancer.

OCE interviewed author and journalist Nathan Vardi, a managing editor at MarketWatch and former senior editor at Forbes. He writes about big money investors, hedge funds, private equity firms, and the intersection of Wall Street and biopharma and is author of the book “For Blood and Money.”

The purpose of this discussion was educational and not an endorsement of the author or his publications. The views and opinions expressed do not represent those of the U.S. Food and Drug Administration.

FDA Meetings with Patients and Advocates

OCE is committed to attending major oncology conferences and meetings. We enjoy meeting with patients and advocates, while also adding to the wealth of scientific data about cancer research. Where will we see you next year?

Clockwise from bottom left: OCE Director Richard Pazdur, MD, and OCE Project Community lead Rea Blakey presenting at the Nov. 14, 2023, Friends of Cancer Research Annual Meeting; screenshot of a listening session on breast cancer with the National Coalition of 100 Black Women, Los Angeles Chapter; OCE's Jamie Brewer, MD, (holding microphone) speaking alongside cancer advocacy leaders addressing the 2023 Congressional Black Caucus in Washington, D.C.; OCE Project Orbis lead Angelo de Claro, MD, (third from left) and Dr. Pazdur meeting in November with four patient advocates in Japan.

Getting to Know You!

This issue we are pleased to highlight American Cancer Society’s Patty Davis. What are you currently working on that makes you feel excited or proud? As the American Cancer Society’s nonprofit, nonpartisan advocacy affiliate, ACS CAN is critical to the fight for a world without cancer. ACS CAN is making cancer a top priority for public officials and candidates at the federal, state, and local levels. ACS CAN empowers advocates across the country to make their voices heard and influence evidence-based public policy change as well as legislative and regulatory solutions that will reduce the cancer burden. I am currently working with ACS CAN to secure cosponsors for the Multi-Cancer Early Detection Act. I’m proud to advocate for early detection because I want all people to have access to quality cancer treatment, both in West Virginia and the nation. What has your experience been working with the Oncology Center of Excellence, Project Community? My experience with the Oncology Center of Excellence has been exciting and positive. I am thrilled to have the opportunity to tell others about what West Virginia is doing right for cancer patients, share my experience, and send the message that there is hope for cancer patients. Additionally, I hope others who watch the video will realize that West Virginia and Appalachia care about their communities and bring to light the existing resources in West Virginia, like Bonnie's Bus, that can help others beat cancer, and let others know that West Virginia is making positive advancements to reduce cancer. Please share any advice you or your organization have for other advocates. I want to encourage all advocates to have hope, and not to doubt yourself or count yourself out if you live in a rural area, or you’ve heard the words “you have cancer.” Your story and your perspective have power, using your voice makes an impact, and whether it is with ACS CAN, in your community, or for yourself, you matter, your perspective matters, and don’t give up.

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. Use: Newsletter Nomination for Getting to Know You in the subject line.

Getting to Know OCE!

I am Dr. Lola Fashoyin-Aje, a medical oncologist and Associate Director, Science & Policy Program to Address Disparities in FDA’s Oncology Center of Excellence. I lead Project Equity, an initiative to improve the representation of historically underrepresented populations in cancer clinical trials. These populations include racial and ethnic minorities, older adults, individuals who live in rural areas, sex and gender minorities, and others. In this role, I develop and help implement policies that encourage sponsors of medical products to conduct inclusive research. An example is the draft FDA guidance, Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials, which I wrote initially as an oncology specific-guidance, then it was broadened to FDA-wide in scope. This guidance provides recommendations to sponsors on developing a Race and Ethnicity Diversity Plan to enroll representative numbers of participants from historically underrepresented racial and ethnic populations in the U.S. in clinical trials. Representative research simply means that the research participants resemble the real-world population with the disease based on demographic factors like race, ethnicity, sex, and age, as well as clinical factors. Often, for the safety of research participants, it is not possible to include all patients in a trial. However, when more is known about the drug, the requirements for entry into the trial can be safely relaxed to allow more people to be eligible to participate. I also work with researchers and patient advocacy groups to review entry criteria for some trials to determine if they are unnecessarily strict.  Besides my work on Project Equity, I’m also a Deputy Division Director in one of five clinical divisions in the Office of Oncologic Diseases at FDA. In this role, I lead teams of oncologists and other scientific staff in reviewing data submitted when companies seek FDA approval of cancer drugs.

True or False?

The FDA does not consider the patient perspective during the drug approval process.

Answer: False! The FDA deeply values the experience of patients, and has formal ways of evaluating this during the review process through initiatives including the OCE Patient-Focused Drug Development Program.

Interested in learning more about recent FDA oncology drug approvals? Take a look at these recent ones! 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.

• Enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
• Capivasertib with fulvestrant for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
• Pembrolizumab with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
• Repotrectinib for locally advanced or metastatic ROS1-positive non-small cell lung cancer.
• Pembrolizumab with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer.
• Encorafenib with binimetinib for adult patients with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test.
• Ivosidenib for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.
• Nivolumab for the adjuvant treatment of completely resected stage IIB/C melanoma in patients 12 years and older.

You can find more information about how to use product labeling and the full list of FDA oncology approvals online.

January

• Cervical Cancer Awareness Month

February

• World Cancer Day 2/4
• International Childhood Cancer Day 2/15
• Cancer Prevention Month
• Gallbladder & Bile Duct Cancer Awareness Month

March

• Colorectal Cancer Awareness Month
• Kidney Cancer Awareness Month
• Multiple Myeloma Awareness Month
• Anal Cancer Awareness Day 3/21

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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