INCY - Incyte's retifanlimab wins FDA's Priority Review status

Incyte (INCY) announces that the FDA has accepted for Priority Review its Biologics License Application for retifanlimab, an intravenous PD-1 inhibitor, 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.The BLA submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus ((HIV)) infection."Despite SCAC being a rare disease, its incidence is increasing and its impact is profound," Lance Leopold Group Vice President, Immuno-Oncology Clinical Development, Incyte said.This Priority Review designation shortens the review period by four months as compared to Standard Review. The target action date for retifanlimab is July 25, 2021.

For further details see:

Incyte's retifanlimab wins FDA's Priority Review status