Incyte : FDA Issues Complete Response Letter For Retifanlimab

(RTTNews) - Incyte Corp. (INCY) said that the U.S. Food and Drug Administration has issued a Complete Response Letter regarding its Biologics License Application or BLA for retifanlimab, an intravenous PD-1 inhibitor, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy.

The complete response letter states that the FDA cannot approve the application in its present form.

The FDA determined that additional data are needed to demonstrate the clinical benefit of retifanlimab for the treatment of patients with advanced or metastatic Squamous Cell Carcinoma of the Anal Canal.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.