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Retifanlimab

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September 14, 2024
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Retifanlimab regimen improves outcomes in advanced anal cancer

The addition of retifanlimab to standard first-line chemotherapy improved outcomes for certain patients with advanced squamous cell carcinoma of the anal canal, according to randomized phase 3 study results presented at ESMO Congress.

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March 22, 2023
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FDA grants accelerated approval to Zynyz for metastatic, recurrent Merkel cell carcinoma

The FDA granted accelerated approval to retifanlimab-dlwr for treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.

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July 26, 2021
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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.

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June 24, 2021
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Advisory panel recommends FDA defer decision on retifanlimab for anal cancer subset

FDA’s Oncologic Drugs Advisory Committee today voted 13 to 4 to recommend deferral of a regulatory decision on retifanlimab for the treatment of certain patients with squamous cell carcinoma of the anal canal.

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January 22, 2021
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FDA grants priority review to retifanlimab for anal cancer subset

The FDA granted priority review to retifanlimab for treatment of certain patients with squamous cell carcinoma of the anal canal, according to the agent’s manufacturer.