July 14 (Reuters) – The U.S. FDA has approved Celcuity’s drug for an advanced form of breast cancer, the regulator said on Tuesday, making it the company’s first product to gain market entry and sending its shares up 7% in afternoon trading.
The U.S. Food and Drug Administration’s approval was based on late-stage data showing the drug, gedatolisib, branded as Revtorpyk, when combined with Pfizer’s Ibrance and fulvestrant, reduced the risk of disease progression or death by 76% compared with fulvestrant alone.
Revtorpyk is intended to treat patients with advanced breast cancer whose tumors have low levels of a protein called HER2 and no mutation in a gene called PIK3CA, and whose disease has worsened after hormone therapy and a CDK inhibitor, a type of therapy.
Patients receiving the combination remained progression-free for a median of 9.3 months, compared with 2.0 months for patients receiving fulvestrant alone.
(Reporting by Kunal Das and Christy Santhosh in Bengaluru; Editing by Pooja Desai)
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