US FDA Approves Gedatolisib Combination Therapy for HR+ HER2- Advanced Breast Cancer

The US FDA has approved gedatolisib (Revtorpyk) in combination with fulvestrant, with or without palbociclib, for the treatment of adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation whose disease has progressed on or after at least one line of endocrine therapy in the metastatic setting. Gedatolisib is a kinase inhibitor that has demonstrated pro-apoptotic and antiproliferative activity, reducing tumor cell growth in both in vitro and in vivo studies. Clinical evidence The approval was based on results from the VIKTORIA-1 clinical trial, which enrolled 392 patients and evaluated gedatolisib plus fulvestrant and palbociclib (Arm A), gedatolisib plus fulvestrant (Arm B), and fulvestrant alone (Arm C).

Median progression-free survival (PFS) was 9.3 months in Arm A, 7.4 months in Arm B, and 2.0 months in Arm C. Objective response…