Overview
- The U.S. Food and Drug Administration approved gedatolisib, branded Revtorpyk, on Tuesday after late‑stage trial data showed the three‑drug combo cut the risk of progression or death by 76% and extended median progression‑free survival to 9.3 months versus 2.0 months.
- The approval covers patients with HER2‑low tumors that lack a PIK3CA mutation whose disease progressed after hormone therapy and a CDK4/6 inhibitor, and Revtorpyk is to be given with Pfizer’s Ibrance (palbociclib) and fulvestrant.
- The approved label records substantial tolerability problems: mouth inflammation affected 72% of patients, 22% had severe cases, and 12% stopped treatment because of side effects, and the label recommends preventive mouthwash.
- Celcuity said it will delay the commercial launch to late Q3 to secure adequate supply, investors pushed the stock down about 8% in premarket trading, and analysts say undisclosed premium pricing plus safety management will shape uptake.
- As Celcuity’s first marketed product, Revtorpyk’s real‑world success will hinge on whether clinicians can prevent and treat oral mucositis, whether patients stay on therapy, and how quickly the company delivers reliable supply and final pricing.