FDA Approves Gedatolisib for Advanced Breast Cancer

July 30, 2026 at 11:06

The FDA approved gedatolisib (Revtorpyk, Celcuity Inc) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2−), locally advanced or metastatic breast cancer without a detected PIK3CA mutation. Eligible patients must have experienced disease progression on or after at least 1 line of endocrine therapy in the metastatic setting.

The approval was based on the PIK3CA wild-type cohort of VIKTORIA-1 (NCT05501886), an open-label, global, randomized phase 3 trial. The study evaluated gedatolisib plus fulvestrant, with or without palbociclib, after disease progression on or after CDK4/6 therapy and an aromatase inhibitor.

Median progression-free survival (PFS) was 9.3 months with the gedatolisib, palbociclib, and fulvestrant triplet and 2.0 months with fulvestrant alone (hazard ratio [HR], 0.24; 95% CI, 0.17-0.35; P<.0001). The objective response rate (ORR) was 32% versus 1%, respectively, and median duration of response (DOR) with the triplet was 17.5 months.

With gedatolisib plus fulvestrant, median PFS was 7.4 months, compared with 2.0 months for fulvestrant alone (HR, 0.33; 95% CI, 0.24-0.48; P<.0001). ORR with the doublet was 28%, and median DOR was 12.0 months. Median DOR could not be determined for fulvestrant because only 1 objective response occurred.

The prescribing information carries warnings and precautions for stomatitis, dermatologic adverse reactions, hyperglycemia, and embryo-fetal toxicity. Stomatitis occurred in 72% of patients receiving the triplet, including grade 3 events in 22%, and in 58% receiving the doublet, including grade 3 events in 12%. Celcuity said it expects to launch Revtorpyk commercially in late third-quarter 2026.