The FDA approved gedatolisib, branded as Revtorpyk, on July 14, 2026, for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation, marking the first targeted therapy option for this patient population.
The approval was based on data from the Phase 3 VIKTORIA-1 trial, which enrolled 392 patients with HR-positive, HER2-negative advanced breast cancer. In the trial, patients receiving gedatolisib in combination with fulvestrant and palbociclib achieved a median progression-free survival of 9.3 months, compared to 2.0 months for those on fulvestrant alone—a hazard ratio of 0.24. Patients receiving gedatolisib with fulvestrant alone (without palbociclib) showed a median PFS of 7.4 months versus 2.0 months for the control group (hazard ratio 0.33). The objective response rate in patients with measurable disease was 32% for the triple-combination arm and 28% for the dual-combination arm, versus just 1% for the control.
The drug is administered as an intravenous infusion of 180 mg once weekly on days 1, 8, and 15 of every 28-day cycle. Celcuity, the manufacturer, expects to launch gedatolisib commercially in the late third quarter of 2026 and plans an expanded access program to bridge eligible patients to commercial availability. The approval addresses approximately 60% of HR-positive, HER2-negative advanced breast cancer cases—those without PIK3CA mutations—representing a significant treatment advance for a patient population that previously lacked targeted therapy options.
The FDA’s approval used the Real-Time Oncology Review program, which streamlined data submission prior to the full clinical application filing, accelerating the review timeline. At the time of the PFS analysis, overall survival data were not yet mature, with 25% of deaths recorded in the overall study population. The prescribing information includes warnings for stomatitis, dermatologic adverse reactions, hyperglycemia, and embryo-fetal toxicity.
Sources
- FDA — Official approval statement and efficacy/safety data from VIKTORIA-1 trial
- Fred Hutchinson Cancer Center — Confirmation of FDA approval and launch timeline
- Targeted Oncology — Patient population eligibility (60% of HR+/HER2- cases)
- The American Journal of Managed Care — Commercial launch plans and expanded access program details
