The FDA approved Celcuity’s Revtorpyk (gedatolisib) for a defined subset of HR-positive/HER2-negative advanced or metastatic breast cancer patients without a PIK3CA mutation, as a first commercial milestone for the company. Approval covers use in combination with fulvestrant following progression on or after at least one line of endocrine therapy in the metastatic setting. Celcuity said Revtorpyk is the first therapy in a new drug class addressing the PAM pathway inhibitor target, and it is preparing for launch while continuing development for broader cohorts. Market reaction in the article focused on uncertainty around timing, not the approval itself. The clearance is notable for biotech commercial planning because it adds a nontraditional pathway inhibitor option for biomarker-defined breast cancer patients, potentially opening additional label expansion opportunities.