FDA accepts Celcuity’s Revtorpyk application for expanded breast cancer use
CELC•The FDA accepted Celcuity’s supplemental application for Revtorpyk (gedatolisib) to treat HR+/HER2-negative, PIK3CA-mutated advanced breast cancer after progression on metastatic endocrine therapy. The agency set a target decision date of June 25, 2027.
1. FDA review accepted
The FDA accepted Celcuity’s supplemental application for Revtorpyk (gedatolisib) for HR+/HER2-negative, PIK3CA-mutated advanced breast cancer following progression on metastatic endocrine therapy. The agency set a target decision date of June 25, 2027.
