Celcuity Enters Commercial Stage as FDA Approves REVTORPYK for Advanced Breast Cancer

Celcuity won full FDA approval for gedatolisib, now branded REVTORPYK, in a specific advanced breast cancer population, moving the company into the commercial stage. The drug is approved for HR-positive, HER2-negative, PIK3CA-wild-type locally advanced or metastatic breast cancer after endocrine therapy progression. VIKTORIA-1 trial results supported the approval, showing meaningful progression-free survival gains versus fulvestrant alone. The triplet regimen cut the risk of progression or death by 76%, while the doublet reduced it by 67%. Celcuity is preparing a broad launch , with a 100-person sales force and an expected commercial rollout later in the third quarter, depending on drug supply. The company also plans additional filings for PIK3CA-mutant disease in the U.S. and abroad, and says pricing will be set at a premium to current therapies.

Celcuity NASDAQ: CELC said the U.S. Food and Drug Administration has granted full approval to gedatolisib, now branded as REVTORPYK, for certain patients with advanced breast cancer, marking the company’s transition to a commercial-stage business. Brian Sullivan, Celcuity’s co-founder and chief executive officer, said on a conference call that REVTORPYK was approved in the United States for the treatment of HR-positive, HER2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after one or more lines of endocrine therapy in the metastatic setting.

“This approval is a transformative milestone for Celcuity as we now transition to a fully integrated commercial stage company,” Sullivan said. FDA Label Covers Use With Fulvestrant, Wit...