Policy & Regulation
Incyte granted FDA priority review for retifanlimab BLA for SCAC
22 January 2021 -

Biopharmaceutical company Incyte (Nasdaq:INCY) disclosed on Thursday that the US Food and Drug Administration (FDA) has accepted for priority review its Biologics License Application (BLA) for retifanlimab.

An intravenous PD-1 inhibitor, retifanlimab is being reviewed as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.

SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers.

Patients with metastatic SCAC have a poor five-year survival, and there are no FDA-approved treatments for patients who have progressed after first-line chemotherapy.

The Prescription Drug User Fee Act (PDUFA) target action date is 25 July 2021.

Incyte's BLA submission is based on data from the company's Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. The trial enrolled 94 patients and resulted in an objective response rate (ORR) of 14% for retifanlimab monotherapy. Retifanlimab 500 mg is administered intravenously every four weeks.

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