# FDA Approves Gedatolisib for ER-Positive, HER2-Negative Metastatic Breast Cancer

> fda · REPORTED · 2026-07-15

The FDA approved gedatolisib (Revtorpyk), a multi-targeted PI3K/AKT/mTOR pathway kinase inhibitor, for locally advanced or metastatic ER+/HER2- breast cancer patients whose disease progressed after at least one line of endocrine therapy in the metastatic setting. Approval was based on results from the VIKTORIA-1 trial led by Fred Hutch's Dr. Sara Hurvitz.

About Pfizer / Eli Lilly (gedatolisib): Gedatolisib is a multi-targeted kinase inhibitor developed for patients with ER-positive, HER2-negative metastatic breast cancer, blocking multiple nodes of a key tumor-growth signaling pathway.

- Company: Pfizer / Eli Lilly (gedatolisib)
- Sector: oncology
- Primary source: https://www.fredhutch.org/en/news/center-news/2026/07/fda-approves-new-breast-cancer-drug-viktoria-study-metastatic-mbc.html

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