Celcuity wins FDA approval for Revtorpyk (gedatolisib) in HR+/HER2- advanced breast cancer

On 22 July 2026 the US Food and Drug Administration approved Celcuity's Revtorpyk (gedatolisib) for adults with hormone-receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation, used in combination with fulvestrant and palbociclib (Ibrance). It is the first approval for Minnesota-based Celcuity and the commercial debut of gedatolisib, a pan-PI3K/mTOR inhibitor.

The decision was based on the Phase 3 VIKTORIA-1 trial. Patients on the gedatolisib triple combination remained free from disease progression for a median of 9.3 months, versus 2.0 months for those on fulvestrant alone - a 76% reduction in the risk of disease progression or death. HR+/HER2- disease accounts for roughly 70% of all breast cancer cases; Celcuity estimates Revtorpyk could address a market of around $6bn in the US.