|
Upcoming FDA Oncology Events
Join us for a vital public panel discussion on a topic important to women’s health in recognition of Gynecologic Cancer Awareness Month: "Endometrial Cancer: Rising Incidence, Rising Innovation" on September 18, 2025.
Why This Matters
Endometrial cancer has become the most common and the deadliest gynecologic cancer in the U.S. This year alone, nearly 70,000 Americans will be diagnosed, and almost 14,000 will lose their lives to this disease. Yet for decades, patients faced a devastating treatment desert. After one drug was approved in 1971, patients waited 48 years for the next breakthrough. While we've seen promising immunotherapy advances since 2019, too many patients still face limited options when these treatments fail.
This panel will address the critical questions that shape the future of endometrial cancer care:
- The long history of stalled drug development
- Rising case numbers and death rates
- Real patient and family experiences with this disease
- What clinical research priorities should guide us forward
As healthcare providers and advocates for patients with cancer, you understand that behind every statistic is a person, a family, a story that deserves to be heard. Your perspectives on patient needs, treatment access, and research priorities are essential to this conversation.
Join us for this free, online event. If you miss the live event, watch any time after the discussion begins on September 18.
This is part of the FDA's "Conversations on Cancer: Making Cancer Personal" series - because every cancer IS personal.
The FDA Oncology Center of Excellence invites you to participate in a significant milestone event in cancer clinical research: the 10th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop, taking place virtually on October 8, 2025.
This workshop provides an essential forum for multidisciplinary collaboration among researchers, clinicians, regulatory professionals, patient advocates, and industry stakeholders. Together, we will advance our understanding of the regulatory and scientific landscape surrounding patient-reported outcome (PRO) measures in cancer clinical trials.
This year's program will feature comprehensive review of the FDA guidance on core PROs finalized in 2024, along with practical examples of how these core outcomes have been successfully integrated into oncology product labeling. The workshop offers unique insights into real-world applications of patient-generated data in regulatory submissions.
Key Workshop Objectives
The free public workshop will address critical topics including:
- Integration of patient-generated data in regulatory submissions over the past decade
-
Research advances in patient-reported outcomes analyses
- Historical case studies of core outcomes data in anti-cancer product labeling
- Current utilization of PRO core outcomes in cancer drug development
- Future directions for PRO data analysis and visualization, including Project Patient Voice
-
Essential milestones for the next five years
Why Participate
As we reflect on a decade of progress in this field, this workshop represents a unique opportunity to learn from regulatory experts, share experiences, and contribute to the ongoing evolution of patient-focused drug development in oncology. The insights gained will help inform best practices for incorporating patient voice into cancer clinical trials and regulatory decision-making.
The FDA Oncology Center of Excellence and The Osteosarcoma Institute cordially invite you to participate in a critical workshop addressing the persistent challenges in osteosarcoma drug development.
FDA/OSI Workshop: Advancing Osteosarcoma Drug Development – Connecting Research and Regulatory Pathways for Improved Outcomes
-
Date: Friday, October 10, 2025
-
Time: 9:30 AM – 5:00 PM Eastern Time
-
Location: Lincoln Square, Washington DC + Virtual attendance available
-
Registration Deadline: September 24, 2025 (in-person); Virtual registration remains open
This interdisciplinary workshop will convene key stakeholders to address three primary objectives:
- Identify opportunities for advancing clinical development through enhanced collaboration
- Increase efficiency within osteosarcoma drug development pipelines
-
Develop innovative strategies for clinical trial design and implementation
Given the urgent unmet medical need in osteosarcoma, your expertise and participation are vital to advancing meaningful therapeutic progress.
 For many small biotech companies and academic institutions, navigating FDA regulations can be daunting. For project teams supported by academic life science accelerators and small businesses, OCE's Project Catalyst offers Accelerator Innovator Discussion (AID) meetings—a 90-minute interaction with experts across FDA offices and centers.
These meetings are informal, non-binding scientific discussions that can help answer early-phase drug development questions regarding oncology therapeutics—from avoiding unnecessary challenges to understanding guidance documents and everything in between.
If your team or small business (under 20 employees) is interested in coordinating a meeting, please Register Here.
New FDA Guidance Documents in Oncology
Approaches to Assessment of Overall Survival in Oncology Clinical Trials
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development
Visit Oncology Guidance
Project Socrates: Educational Opportunities
FDA Oncology offers free educational programs for anyone interested in regulatory science and drug development. Check out Project Socrates for more information.
|
|
