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FDA Enhances Global Patient and Regulatory Collaborations in Oncology

Feb. 1 Virtual Discussion to Highlight Successes from Development to Approval

FDA Oncology Center of Excellence and the European Medicines Agency Present Conversations on Cancer. Transforming Patient Lives by Therapeutic & Regulatory Innovations. Thursday, February 1, 2024. 9:30 - 11:30 AM ET • 3:30 - 5:00 PM CET, Virtual

By: Vaibhav Kumar, M.D., M.S., Division of Oncology 3, Office of Oncologic Disease, and Rea Blakey, Associate Director, Oncology Center of Excellence, External Outreach and Engagement

Over the past two decades, rapid gains in the understanding of complex tumor biology have led to numerous groundbreaking therapeutic advances for many cancers, most notably in chronic myeloid leukemia (CML), multiple myeloma, and melanoma. The treatment landscape for these cancers, which increasingly utilize the promise of precision medicine, is now vastly different from the non-targeted, poorly tolerated approaches of the past. The use of expedited approval pathways has led to transformative gains in the quality of life and survival for patients with these conditions both in the U.S. and globally. The development of these transformative therapies has also benefitted tremendously from increasingly globalized and connected patient advocacy networks that raise awareness of, and encourage participation in, clinical trials that have shaped modern cancer care. 

Vaibhav Kumar, M.D., M.S.
Vaibhav Kumar, M.D., M.S.

Recognizing the importance of international collaboration from patients, investigators, industry, and regulators, is paramount to facilitate ongoing development and expedited access to innovative cancer therapies. For example, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) for two decades have exchanged information and regulatory cooperation on a range of topics, including oncology. Project Orbis, an initiative led by the FDA Oncology Center of Excellence (OCE) that provides a framework for concurrent submission and review of oncology products among international partners, has further enhanced collaboration across several international regulatory agencies. 

World Cancer Day, Feb. 4, is an international day to raise awareness of cancer prevention, detection, and treatment, and to support collaborative efforts to reduce suffering and death due to cancer. In recognition of World Cancer Day 2024, the FDA and EMA will collaborate to spotlight innovative cancer treatment advances for patients with CML, multiple myeloma, and melanoma. The virtual public discussion takes place on Feb. 1, “Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations,” from 9:30 – 11 a.m. ET / 3:30– 5 p.m. CET, and we invite you to register.

In this discussion, U.S. and European patient advocates, scientific investigators, and regulators, will exchange ideas about the pace of drug development for impactful therapies. The discussion will provide an overview of regulatory programs that expedite access to patients, including FDA’s Breakthrough Therapy Designation and Accelerated Approval, and EMA’s PRIME and Conditional Approval. The panel aims to highlight successes and lessons learned from development to approval.

Rea Blakey, Associate Director for External Outreach and Engagement, OCE
Rea Blakey

Panel members include patients and leaders from International Myeloma Foundation, Melanoma Patient Network Europe, and Patvocates, all with a focus on patient advocacy and patient centered research and development. They will be joined by U.S. and European clinical investigators and regulators.

The international public discussion is the second such collaboration between the FDA and EMA,  and is facilitated by OCE’s Project Community. The first discussed international perspectives on “Living with Metastatic Breast Cancer” offering experiences for patients and investigators across Europe and the U.S. A common theme was expediting access to quality care and the importance of transparent public engagement in addressing the root causes for cancer care inequities and clinical trial participation. 

The FDA looks forward to ongoing collaborations with EMA. Improving global patient engagement consistent with the goals of patient centered drug development is key, and we look forward to hearing from patients, investigators, and regulators at the Conversations on Cancer on Feb. 1.


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