Greetings from FDA Oncology!
Welcome to the April 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.
OCE Director's Message
Hi Patients, Advocates and Families,
I appreciated meeting with so many of you during AACR in San Diego earlier this month. It’s a pleasure hearing your feedback on our work at the FDA Oncology Center of Excellence: some positive remarks, some areas where OCE can expand. Either way it’s welcomed! Your feedback resulted in the creation of this newsletter one year ago!
We’re proud to announce, for the first time ever, an OCE Conversation on Cancer public panel discussion led by advocates! Register below for “Strength in Numbers, Increasing Cancer Awareness while Decreasing Disparities."
We hope you enjoy our Conversations on Cancer series. Already there have been four of these public panel discussions this year including our second international session for World Cancer Day in February.
We look forward to your creative participation in the fourth annual National Black Family Cancer Awareness campaign June 13-19, 2024. Gear up for your social media content supporting #BlackFamCan across all platforms and register for the June 13 public panel discussion, too!
Sincerely,
Richard Pazdur, MD • OCE Director
|
Upcoming Events
Conversations on Cancer
 Click the graphic above to register for the April 23 Conversations on Cancer!
April is National Minority Health Month, created to reduce health disparities and raise awareness about improving the health of racial and ethnic minority communities. In March 2023, the White House also proclaimed April as National Cancer Control Month to encourage greater cancer prevention and early detection.
In appreciation of both, OCE’s Conversation on Cancer series is featuring voices of diverse cancer advocacy groups to lead this month’s public panel discussion entitled, “Strength in Numbers, Increasing Cancer Awareness While Decreasing Disparities.” Register here.
Working or too busy to watch Conversations on Cancer? Catch up by viewing past events posted on the Conversations on Cancer web page!
National Black Family Cancer Awareness Week
 Registration is now open for the free Conversations on Cancer public panel discussion on June 13, 2024, highlighting National Black Family Cancer Awareness Week.
Participants in the 2024 National Black Family Cancer Awareness Week social media campaign #BlackFamCan, June 13-19, are welcome to address any relevant topics of interest in your communities. OCE Project Community is recommending the following, in conjunction with White House Cancer Moonshot goals:
- Thursday, June 13—Emphasize efforts to close the cancer screening gap.
- Friday, June 14—Understand and address cancer-related environmental exposure.
- Saturday, June 15—Support “Engaging the Generations” for Juneteenth and Father’s Day Weekend.
- Sunday, June 16—Support “Engaging the Generations” for Juneteenth and Father’s Day Weekend.
- Monday, June 17—Emphasize the harmful impact of tobacco use and decrease the impact of preventable cancers (4th Annual Juneteenth Federal Holiday).
- Tuesday, June 18—Support cancer research among patients and communities.
- Wednesday, June 19—Support patients and caregivers.
ICYMI (In Case You Missed It)
Conversations on Cancer:
March 19, 2024: Conversations on Cancer – ODAC Chronicles - the Past, Present, and Future of Oncology Advisory Committees. Watch on YouTube.
This discussion focused on the role of the Oncologic Drugs Advisory Committee in the FDA’s regulatory review process. The session provided deep insight into the considerations for ODAC member selection and what preparing for an ODAC meeting entails. The panel included past and current ODAC members and regulators. It showed how ODAC is an integral part of the FDA assessment.
February 27, 2024: Conversations on Cancer Black History Month Program—Real Talk: Our Stories as Black Oncologists at the FDA. Watch on YouTube.
Our 6th annual Conversations on Cancer program commemorating Black History Month featured several African American medical oncologists who work at FDA discussing their experiences, perspectives, and advice. Recently, the American Society of Clinical Oncology released data showing that African Americans will likely continue to be under-represented in medical oncology and African Americans compose only 4% of hematology/oncology fellows in the United States.
February 1, 2024: Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations. Watch on YouTube.
This Conversation on Cancer, in recognition of World Cancer Day, was the second collaboration between OCE and the European Medicines Agency in this public panel discussion series. The conversation focused on the introduction of certain innovative therapeutic classes in the past two decades that have revolutionized the care for patients with chronic myeloid leukemia, multiple myeloma, and melanoma.
Patients and Advocates at Recent Meetings
 |
|
A few of the amazing advocates we met at Advancing the Science of Cancer in Latinos, held in San Antonio, TX, in February!
At left, Yvonne Rodriguez (Fairfax, VA), Marco Perez (Horizon City, TX); Tatiana Puga (San Antonio, TX).
|
 Above, the Latin Cancer Patient Advocate Training Program participants.
In early April, several members of OCE's leadership met with advocates at the American Association for Cancer Research Annual Meeting, in San Diego, and answered questions on a variety of topics including accelerated approval, diversity action plans for clinical trials, pediatric drug development, immunotherapy, and artificial intelligence.
Below: OCE Director Richard Pazdur (far right at lectern) and OCE Deputy Directors Marc Theoret (far left) and Paul Kluetz (center), Division of Oncology 2 Director Harpreet Singh (second from left) and former OCE Project Equity lead 'Lola Fashoyin-Aje (fourth from left).
 Advocates and a few other FDA oncologists and staff filled the room at the AACR session. Advocates also participated in or attended many of AACR's Regulatory Science and Policy sessions that included FDA experts.
Getting to Know You!
This issue we are pleased to highlight Barbara Segarra.
What are you currently working on that makes you feel excited or proud?
I am very proud to be offering the 1st Latino Cancer Patient Advocate Program in the United States. As a two-time breast cancer survivor, I have been a cancer research patient advocate for more than 12 years. During all these years I have noticed a very low number of Latino advocates. This triggered the idea of developing a training for Latino advocates to increase our voices and our participation in the different aspects of research.
Latinos are the fastest growing minority in the U.S. and cancer is the first cause of death in women and men in this population. Therefore, there is a need to reach out to the Latino community and have representation in decision making committee. Latino advocates should be working with researchers to help them understand the Latino community. We received 33 applications and selected 15 participants to join this new program. The participants are patients, survivors or caregivers impacted by different types of cancer. All of them are also Latinos.
The program consisted of two virtual sessions, a face-to-face training session and their participation in the conference Advancing the Science of Cancer in Latinos held in San Antonio, Texas, in February. The training has included the following topics: Patient Advocacy, Cancer by the Numbers, Basics of Cancer Science, Clinical Trials, GRASP, Drug Development, and Resources for Patients and Advocates. We will have two other virtual sessions on topics identified of interest by the participants.
My goal is to build a network of Latino advocates where we can help each other, share opportunities for advocates that our network could benefit from, and most of all, be able to communicate the needs of our Latino community and increase their participation in clinical trials. Education is the key, and through this program, I hope to amplify the Latino voices to continue to work towards eliminating health disparities. This blog published after the Latino Conference, includes a summary of the Program and some of the participants experience First-Ever Cancer Patient Advocate Training Program Saves Seat at the Table for Latinos - Salud America (salud-america.org).
What has your experience been working with the Oncology Center of Excellence, Project Community?
I am grateful for the opportunity to work with the Oncology Center of Excellence Project Community writing about the Latino Training Program. I admire the efforts of the Center in working with the community and helping disseminate the work that they do. This helps establish collaborations and new projects.
Please share any advice you or your organization have for other advocates.
My advice for other advocates will be to not be afraid of speaking up. As patients, caregivers, and advocates, we have the real-life experience that can help guide science and policies. I would encourage advocates, especially those from minority populations, to share the needs of the community. Share the stories and the barriers people must go through just to get what we all deserve. Take advantage of participating in committees and forums where you can have a voice. Just by sitting at the table can help people see things that they might not have thought off before. We must get involve and be present. So please, never get tired of advocating for health equity for all.
|
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!
Geetika Srivastava MD, MSPH, is a hematologist- medical oncologist who leads the Oncology Center of Excellence initiative Project Asha, a collaboration with White House Cancer Moonshot program to increase cancer care access and oncology clinical trial participation in India.
Diverse multiregional global trials participation not only better reflects the racially and ethnically diverse U.S. population, but globalization of research also has an immense public health, economic, social, and ethical implication.
As an FDA regulatory reviewer, Dr. Srivastava focuses on gastrointestinal (GI) malignancies. She serves as vice chair of the FDA committee for the American Society of Clinical Oncology's annual conference on GI malignancies. She’s a medical officer in the Division of Oncology 3, Office of Oncologic Diseases, at the Center for Drug Evaluation and Research, FDA.
Dr. Srivastava also treats oncology patients at the Washington DC Veterans Affairs Medical Center.
Prior to joining FDA in 2022, Dr. Srivastava served as the Oncology Section Chief at Memorial Hospital, University of Colorado, in Colorado Springs. She received her training at All India Institute of Medical Sciences in New Delhi, India, then received a Master of Epidemiology degree at University of Texas, Houston, and worked as a graduate assistant at MD Anderson Cancer Center. She completed her residency training in Internal Medicine at University of Arkansas, Little Rock, and hematology-medical oncology fellowship at Mayo Clinic, Rochester, MN.
|
True or False?
True or False? Oncology drugs approved under accelerated pathways are not rigorously evaluated.
False! Drugs approved under accelerated pathways must undergo post-market studies to confirm their clinical benefit, and the FDA can withdraw approval if these studies fail. For more information, check out OCE’s Project Confirm.
 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, which is 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.
March 22, 2024: Mirvetuximab soravtansine-gynx for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
March 19: Ponatinib with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). Accelerated approval.
February 16: Lifileucel, a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.
February 15: Tepotinib for adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
February 13: Liposomal irinotecan with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.
You can find more information about how to use product labeling and the full list of FDA oncology approvals.
 April
- Esophageal Cancer Awareness Month
- National Cancer Control Month
- National Minority Cancer Awareness Month
- National Oral, Head, and Neck Cancer Awareness Month
- National Young Adult Cancer Awareness Week
- Testicular Cancer Awareness Month
May
- Bladder Cancer Awareness Month
- Brain Tumor Awareness Month
- National Melanoma/Skin Cancer Detection and Prevention Month
- Oncology Nursing Month
June
- Cancer Survivors Month
- June 13 - 19, 2024 - National Black Family Cancer Awareness Week
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.
Subscribe to OCE Engagement | Manage Subscriptions | Unsubscribe All | Help
|
