# FDA Approves Revtorpyk (Gedatolisib) for HR+/HER2- PIK3CA Wild-Type Advanced Breast Cancer

> fda · REPORTED · 2026-07-14

On July 14, 2026, the FDA approved gedatolisib (Revtorpyk, Celcuity) in combination with fulvestrant, with or without palbociclib, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation, following the Phase 3 VIKTORIA-1 trial showing a 76% reduction in progression risk for the triplet regimen. NCCN subsequently designated it a preferred Category 1 regimen, with commercial launch expected by end of Q3 2026.

About Celcuity (Revtorpyk / gedatolisib) — sector event: Celcuity is a biotechnology company developing and commercializing targeted therapies for solid tumors, with Revtorpyk being its first FDA-approved product — a pan-PI3K and mTORC1/2 inhibitor targeting the PAM pathway in breast cancer.

- Company: Celcuity (Revtorpyk / gedatolisib) — sector event
- Sector: oncology
- Primary source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.