FDA Approval Insights: Gedatolisib Plus Fulvestrant ± Palbociclib for HR+, HER2-Negative, PIK3CA Wild-Type Advanced Breast Cancer: With Adam M. Brufsky, MD, PhD

In today’s episode, we spoke with Adam M. Brufsky, MD, PhD, about the FDA approval of gedatolisib (Revtorpyk) plus fulvestrant (Faslodex), with or without palbociclib (Ibrance), for the treatment of adult patients with hormone receptor–positive, HER2-negative advanced breast cancer without a PIK3CA mutation following progression on or after treatment with 1 or more lines of endocrine therapy in the metastatic setting. Dr Brufsky is a professor of medicine and the associate division chief for the Division of Hematology/Oncology in the Department of Medicine at the University of Pittsburgh School of Medicine; as well as medical director of the Magee-Women’s Cancer Program, associate director for clinical investigations, and codirector of the Comprehensive Breast Cancer Center at the University of Pittsburgh Medical Center Hillman Cancer Center, in Pennsylvania.

In our exclusive interview, Dr Brufsky highlighted the significance of this approval, key efficacy and safety data from Study 1 of the phase 3 VIKTORIA-1 trial (NCT05501886) that supported this regulatory decision, and what the future may hold for metastatic breast cancer management strategies.