Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer
Celcuity Inc. has submitted a supplemental New Drug Application to the FDA seeking approval of REVTORPYK (gedatolisib) for treatment of hormone receptor positive, HER2-negative locally advanced or metastatic breast cancer patients with PIK3CA mutations. This follows positive Phase 3 VIKTORIA-1 trial results demonstrating significant progression-fre…