Celcuity says FDA approves REVTORPYK for HR+/HER2- PIK3CA wild-type metastatic breast cancer
CELC•Trial results and launch timing
VIKTORIA-1 showed a PFS of 9.3 months with REVTORPYK, palbociclib and fulvestrant versus 2.0 months with fulvestrant alone.
Celcuity said a commercial launch is targeted for late Q3 2026, and an expanded access program is planned ahead of launch.
FDA approves REVTORPYK in metastatic breast cancer
Celcuity says the FDA has cleared REVTORPYK (gedatolisib) for HR+/HER2- metastatic breast cancer with PIK3CA wild-type disease.
The label covers patients whose cancer progressed on or after at least one line of endocrine therapy in the metastatic setting.
