Posted by Michael Wonder on 24 Jul 2021
Incyte provides regulatory update on retifanlimab for the treatment of certain patients with squamous cell carcinoma of the anal canal
23 July 2021 - Incyte today announced that the U.S. FDA has issued a complete response letter regarding its biologics license application 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.
Consistent with the Oncologic Drugs Advisory Committee recommendation on 24 June 2021, 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.
