EORTC - Combining Immunotherapies, Immune Modulators, and Targeted Therapies: Regulatory Opportunities Challenges
Combining two immunotherapy agents has been shown to produce better tumor regression in early clinical studies. As a result, researchers are now combining immunotherapies, immune modulators, and targeted therapies to achieve better and more durable responses in patients. However, the regulatory approaches, standards, and requirements that are necessary for approving combination immunotherapies are still evolving. Therefore, this timely session examined both the promises and challenges inherent in evidence-based regulatory approval of these therapies. Short presentations from a representative from the U.S. Food and Drug Administration, as well as leaders from academia, industry, and the patient advocacy community were followed by a moderated panel discussion and audience Q&A.
Speakers and Panelists:
- F. Stephen Hodi, MD, director of the Melanoma Center at Dana-Farber/Brigham and Women's Cancer Center and assistant professor of medicine at Harvard Medical School – (chair and moderator)
- Ke Liu, MD, PhD, director, Oncology Branch, Office of Cellular Tissue and Gene Therapies (OCTGT) at the FDA Center for Biologics Evaluation and Research (CBER)
- Michael Postow, MD, Memorial Sloan Kettering Cancer Center and Recipient of the 2013 Conquer Cancer Foundation, Oncology Young Investigator Award
- Renzo Canetta, MD, vice-president of oncology global clinical research at Bristol-Myers Squibb
- Louise Perkins, PhD, chief scientific officer, Melanoma Research Alliance
Watch panel video and audience Q&A.