FDA Approves Gedatolisib (Revtorpyk), First Pan-PI3K/mTOR Inhibitor, for Advanced Breast Cancer

The FDA approved gedatolisib (Revtorpyk, Celcuity) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor-positive, HER2-negative, PIK3CA-wild-type locally advanced or metastatic breast cancer that progressed after at least one line of endocrine therapy in the metastatic setting. Revtorpyk is the only FDA-approved inhibitor of all class I PI3K isoforms (alpha, beta, delta, gamma) plus mTORC1 and mTORC2. In the pivotal VIKTORIA-1 trial, the triplet of gedatolisib, fulvestrant, and palbociclib achieved a median progression-free survival of 9.3 months versus 2.0 months for fulvestrant alone, while the gedatolisib-fulvestrant doublet reached 7.4 months. Celcuity expects to launch the drug commercially in the third quarter of 2026 and plans a supplemental filing for PIK3CA-mutated disease based on the trial's mutant cohort.