This summer, Incyte Corp. hit a roadblock in the company’s quest to have its drug retifanlimab become the first FDA-approved treatment of its kind for patients with the most common type of anal cancer.

Retifanlimab is an immune checkpoint inhibitor (also known as immunotherapy) that aims to treat adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) whose disease has progressed after receiving platinum-based chemotherapy or who were intolerant of that type of chemotherapy. Currently, there are no approved treatment options available to patients who meet these criteria, according to Incyte.

But in a 13-4 decision on June 24, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted to defer a regulatory decision on retifanlimab until more data emerges from an ongoing confirmatory trial called POD1UM-303. Information gleaned from a previous trial — POD1UM-202 — is far from sufficient to support the drug’s approval, the committee said, highlighting questions about the drug’s effectiveness and issues such as the trial enrolling too few HIV-positive patients and racial minorities.

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