# FDA Approves Celcuity's Revtorpyk (Gedatolisib) for Advanced Breast Cancer

> fda · REPORTED · 2026-07-14

The U.S. FDA approved Celcuity's gedatolisib, branded Revtorpyk, on July 14, 2026 as the first PAM pathway inhibitor for HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation, in combination with fulvestrant with or without Pfizer's Ibrance. Phase III data showed a 76% reduction in risk of disease progression or death versus fulvestrant alone.

About Celcuity: Celcuity is a Minneapolis-based biotech that develops targeted oncology therapies focused on the PI3K/AKT/mTOR pathway, primarily for hormone receptor-positive breast cancer and other solid tumors.

- Company: Celcuity
- Sector: oncology
- Primary source: https://www.yahoo.com/news/science/articles/us-fda-approves-celcuitys-breast-193742875.html

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