Posted by Michael Wonder on 22 Jan 2021
Incyte announces acceptance and priority review of BLA for retifanlimab as a potential treatment for patients with squamous cell carcinoma of the anal canal
21 January 2021 - Incyte today announced that the U.S. 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 who have progressed on, or who are intolerant of, platinum-based chemotherapy.
The submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or are intolerant of, standard platinum-based chemotherapy.
