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  • FDA accepts BLA for retifanlimab to treat squamous...

FDA accepts BLA for retifanlimab to treat squamous cell carcinoma of the anal canal .- Incyte

Read time: 1 mins
Published:22nd Jan 2021
Incyte has announced that the FDA has accepted for Priority Review its Biologics License Application (BLA) 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. Retifanlimab has been granted Orphan Drug Designation by the FDA for the treatment of anal cancer, along with Priority Review. The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the review period by four months as compared to Standard Review. The Prescription Drug User Fee Act (PDUFA) target action date for retifanlimab is July 25, 2021. SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers.1 Patients with metastatic SCAC have a poor 5-year survival, and there are no FDA-approved treatments. for patients who have progressed after first-line chemotherapy. Orphan Drug in US.
Condition: Anal Cancer
Type: drug

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