FDA issues complete response letter for retifanlimab for anal cancer

FDA issues complete response letter for retifanlimab for anal cancer

The FDA issued a complete response letter to Incyte indicating it cannot approve the company’s biologics license application that seeks approval of retifanlimab for certain patients with anal cancer.The agency determined additional data are needed to demonstrate the clinical benefit of retifanlimab (Incyte), a PD-1 inhibitor administered via IV.Incyte officials will discuss next steps with the FDA, according to a company-issued press release.Incyte sought approval of retifanlimab for treatment of patients with locally advanced or metastatic squamous cell carcinoma of the anal canal whoRead More

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