Greetings from FDA Oncology!
Welcome to the January 2025 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 2025 and send your suggestions to OCE-Engagement@fda.hhs.gov.
Center Director's Message
Happy New Year Advocates,
We thank all the patients and advocates who share their experiences with OCE. Our work on behalf of the public is greatly enhanced when we hear from you. We want you to continue the open dialogue with OCE in 2025.
I’m extending a special message of appreciation to Jim Dawson, a patient with cancer who recently wrote an unsolicited email to OCE about hope and health. Here’s Jim’s advice, “Always remember you are not alone. Fight with all your might and help others [with] cancer. Support them. Be strong. Bring positive energy. Find positives that enhance your life. Live every day to its fullest. Carry on.”
The first Conversation on Cancer in 2025 is another collaborative effort with the European Medicines Agency (EMA). Register here to watch the January 14 “Conversations on Cancer: Innovations in Cervical Cancer Treatment” public panel discussion from 10 –11 am ET / 4-5 pm CET.
This year OCE is launching Project Connect, which will focus on international cancer patient engagement. To learn more, follow @FDAOncology for updates and register for the February 11 Conversation on Cancer public panel discussion.
OCE has laid the groundwork for Project Connect through strategic efforts to collaborate with other well-established regulators around the globe. An OCE delegation visited Health Canada, Belgium’s Federal Agency for Medicines and Health Products, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency in 2024. During these trips, the OCE team met with patient groups in Ottawa, Canada (September 2024) and in Brussels, Belgium and London, England (November 2024). Regardless of geographic location, these meetings with patients provide valuable perspectives and continue to guide our regulatory decision-making.
OCE recently conducted a Conversation on Cancer, in conjunction with the EMA, which examined an array of challenging decisions faced by members of the pediatric oncology community.
We look forward to many more discussions with you in 2025!
Sincerely,
Richard Pazdur, MD • OCE Director
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Upcoming Events
Conversations on Cancer
 January 14, 2025: Conversations on Cancer: Cervical Cancer Treatment Innovation—A Collaborative Discussion, commemorating Cervical Cancer Awareness Month, 10-11 am ET / 16-17:00 CET, virtual. Register Here!
Cervical cancer is the fourth most common cancer in women globally and remains the most common cancer-related cause of death in certain regions. In the last 10 years, a surge in innovation has made anti-PD1 directed therapy and targeted therapies available to patients. In 2024, there were four FDA approvals for cervical cancer. Ongoing research into innovative therapeutic approaches offers renewed hope for patients in the near future.
Join us for an engaging discussion that will bring together key stakeholders in the fight against cervical cancer, including representatives from the patient advocacy community, academia, community oncology, the EMA and the FDA. Together, we will explore the historical path that has led us to the current treatment landscape, the impact of new therapies on individuals with cervical cancer and their families, areas of ongoing high impact research, and what the future might bring.
Conversations on Cancer
 November 19, 2024: Conversations on Cancer – Pediatric Cancers: Navigating the Challenges Together. Watch on YouTube
Each year, over 15,000 children, adolescents, and young adults 0-19 years of age in the U.S. and 300,000 globally are diagnosed with cancer. Although the survival rate for pediatric cancer is approximately 85%, it remains the most common cause of death by disease in children. The most common childhood cancers are leukemia, lymphomas and brain tumors. Incidence, mortality rates, and survival percentages vary among EU countries and regions. For these patients and their families, treatment is often arduous, prolonged, and fraught with challenges.
In conjunction with the EMA, the OCE held a Conversations on Cancer public panel discussion to examine an array of challenging decisions faced by members of the pediatric oncology community.
 October 23, 2024: Conversations on Cancer: Pazdur + 25—Celebrating a Silver FDA Anniversary. Watch on YouTube
OCE Center Director, Richard Pazdur, MD was lauded during an historic Conversation on Cancer panel discussion. The acknowledgement of Dr. Pazdur's FDA tenure was a news-making event that featured several previous FDA Commissioners.
Patients and Advocates at Recent Meetings
 OCE leaders meeting with Health Canada colleagues and Canadian patient advocacy groups: Helena’s Hope, Advocacy for Canadian Childhood Oncology Research Network (AC2ORN), Canadian Rare disorders (CORD), and Best Medicines Coalition.
 OCE leaders meeting with United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) colleagues and UK patient advocacy groups: The Brain Tumour Charity, Cancer Research UK, Cancer52, Independent Cancer Patients’ Voice, and Myeloma UK.
 OCE leaders meeting with FDA EU office colleagues, European Patients Forum staff, Cancer Patients Europe, Europa Donna Belgium, European Liver Patients’ Association, Europa Uomo, Myeloma Patients Europe, and European Cancer Leagues.
Getting to Know You!
In this issue we are pleased to highlight Tamika Felder, Chief Visionary at Cervivor, Inc. Supporting patient advocacy engagement and other cervical cancer patients pursuing fertility options. Diagnosed with stage IIA cervical cancer in April 2001.
Q: What are you currently working on that makes you feel excited or proud?
With Cervivor’s 20th year on the horizon, I feel incredibly proud and grateful for the organization’s journey and the strength of our cervical cancer community. Our advocacy footprint grows day after day, fueled by our dedicated Cervivor Ambassadors and community members. The ultimate goal is to eliminate cervical cancer, aiming for it to become a rare disease affecting no more than 4 cases per 100,000 women per year by 2030.
This year, Cervivor is committed to an “Every Cervix Counts” approach to awareness, prevention, and support through:
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Outreach: Identifying women and communities at risk of cervical cancer, encouraging regular screenings and follow-up care.
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Education: Sharing vital information about HPV vaccination with parents of vaccine-aged children and individuals under 45.
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Support: Empowering patients, survivors, caregivers, and all those affected by cervical cancer to share their stories, giving a voice to this disease and putting a face to the fight.
Centering patients and their lived experiences has never been more important in healthcare. Their voices ensure that care strategies are patient-centered and guide the development of effective, meaningful treatment plans.
Q: How would you define the value in patients working with the Oncology Center of Excellence, Project Community?
Working with the Oncology Center of Excellence provides unparalleled access to cutting-edge research, comprehensive treatment options, and a multidisciplinary team dedicated to patients with cancer. Their commitment to integrating patient perspectives into regulatory decisions ensures that treatments are not only effective but also compassionate and patient centered.
Q: What advice do you or your organization have for other advocates?
Seek Collaboration: Partner with like-minded advocates and relevant organizations to leverage collective strength and avoid duplicating efforts. Collaboration amplifies impact.
Maximize Resources: If you’re working solo or with a small grassroots group, identify where you can maximize your efforts for the greatest impact within your available resources.
Sustain Your Efforts: Advocacy is a long-term commitment. Avoid burnout by pacing yourself, taking breaks when needed, and remembering the importance of self-care.
Stay Resilient: Don’t give up, even when challenges arise. Your dedication can create lasting change and inspire others to join the cause.
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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!
Dianne Spillman is the Associate Director for Global and Regulatory Outreach in the Oncology Center of Excellence. She oversees and facilitates OCE interactions with foreign regulatory counterparts and was instrumental in the first international collaborative review between Australia, Canada, and the US under Project Orbis. OCE’s collaboration with other regulatory health authorities has led to the approval of numerous therapies for patients with cancer.
Dianne’s government service spans over 30 years, with the majority in FDA oncology Divisions and Offices. After receiving her bachelor’s degree from Northeastern University (Boston, MA), she joined the National Institutes of Health in 1990 as a research assistant. Prior to her current role at OCE, Dianne’s positions at FDA include Regulatory Project Manager with CDER’s Division of Oncology and Pulmonary Drug Products, Special Assistant to Dr. Richard Pazdur, and Lead Project Manager for the Oncology Program in the Office of Hematology and Oncology Products.
In addition to international engagement, Dianne has been involved in coordinating and planning the meetings of the Oncologic Drugs Advisory Committee (ODAC) for over 20 years. The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer.
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Project Community Resources
Project Community's Cancer Community Resources web page has been updated. You can find informational brochures in English, Spanish, Korean, Tagalog, Vietnamese and Chinese, as well as educational videos.
 December 20: Remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older.
December 18: Ensartinib for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.
December 4: Durvalumab for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
December 4: Zenocutuzumab-zbco was granted accelerated approval for adults with the following: advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.
November 20: Zanidatamab-hrii was granted accelerated approval for previously treated unresectable or metastatic HER2-positive biliary tract cancer.
November 15: Revumenib for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.
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.
 January
- Cervical Cancer Awareness Month
February
- National Cancer Prevention Month.
- Gallbladder and Bile Duct Cancer Awareness Month.
- World Cancer Day February 4
March
- International HPV Awareness Day: March 4
- Anal Cancer Awareness Day: March 21
- Triple Negative Breast Cancer Day: March 3
- Kidney Cancer Awareness
- Myeloma Awareness Month
- National Colorectal Cancer Awareness Month
- Brain Tumor Awareness Month
- Ovarian Cancer Awareness Month
- Prostate 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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