Celcuity Wins FDA Nod for Breast Cancer Combo Gedatolisib

The FDA approved Celcuity's Revtorpyk (gedatolisib) for HR+/HER2- breast cancer patients who have received one prior line of endocrine therapy. The drug is given alongside palbociclib and either letrozole or fulvestrant.

Revtorpyk targets the PI3K/mTOR pathway, a mechanism distinct from the CDK4/6 inhibitors that dominate first-line treatment for this subtype. Celcuity now faces the work of building a commercial presence against established products from Pfizer, Novartis, and Eli Lilly.

The company has not disclosed a launch date. Internal guidance pointed to initial sales in the first half of 2026. Celcuity expects to provide a more detailed commercial plan in the coming months.