The U.S. Food and Drug Administration approved gedatolisib (Revtorpyk) on July 14, 2026, for the treatment of patients with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer who do not have a PIK3CA mutation, following progression on at least one line of endocrine therapy in the metastatic setting. Developed by Celcuity Inc., a Minneapolis-based biotechnology company, Revtorpyk is the first and only FDA-approved therapy to inhibit all four class I PI3K isoforms and both mTOR complexes simultaneously.
The approval addresses one of the most significant unmet needs in breast cancer treatment: the approximately 60 percent of second-line HR+/HER2- metastatic breast cancer patients who do not have a PIK3CA mutation and for whom no therapy in this mechanistic class was previously approved. An estimated 37,000 women per year in the United States fall into this category, according to Celcuity's announcement.
