Celcuity Wins FDA Approval For REVTORPYK For The Treatment Of Advanced Or Metastatic Breast Cancer

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source on Google Add Now Celcuity Inc. ( CELC ), a biotechnology company, announced that the U.S. Food and Drug Administration has approved REVTORPYK (gedatolisib) for the treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. Specifically, the approval is for patients with HR+/HER2-, locally advanced or metastatic breast cancer without a detected PIK3CA mutation whose disease has progressed on or after at least one line of endocrine therapy in the metastatic setting. HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers, said Celcuity. The FDA approval was based on the positive Phase 3 VIKTORIA-1 trial, an open-label, global, randomised clinical trial evaluating the efficacy and safety of REVTORPYK plus...