Celcuity Secures First FDA Approval for Breast Cancer Drug Revtorpyk

Celcuity Inc. (CELC) has received approval from the U.S. Food and Drug Administration for its first commercial product, a treatment for an advanced form of breast cancer. The regulatory milestone sent the company's shares up 7% in afternoon trading on Tuesday.

Details of the Approval

The FDA greenlit gedatolisib, which will be marketed under the brand name Revtorpyk. The approval is a landmark achievement for Celcuity, marking its transition from a clinical-stage to a commercial-stage biopharmaceutical company.

Revtorpyk is indicated for patients with advanced or metastatic breast cancer whose tumors have low levels of the HER2 protein and no mutation in the PIK3CA gene. The treatment is intended for patients whose disease has progressed following prior treatment with hormone therapy and a CDK inhibitor.

Compelling Clinical Trial Data

The agency's decision was based on data from a late-stage clinical trial. The study evaluated Revtorpyk in combination with Pfizer’s Ibrance (palbociclib) and the endocrine therapy fulvestrant.

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Key findings from the trial include:

• The combination therapy reduced the risk of disease progression or death by 76% when compared to treatment with fulvestrant alone.
• Patients receiving the Revtorpyk combination had a median progression-free survival of 9.3 months.
• This compares to a median progression-free survival of just 2.0 months for patients who received only fulvestrant.

Market Impact and Context

Investors responded positively to the news, with Celcuity's stock price rising sharply on the announcement. The approval provides a new therapeutic option for a specific patient population with limited choices after their cancer has advanced, representing a significant unmet medical need.