INCY - FDA panel recommends deferring Incyte's retifanlimab BLA decision

Incyte ([[INCY]] +1.0%) said that the U.S. FDA's advisory committee had voted in favor of putting off the regulatory decision on the company's squamous cell carcinoma of the anal canal ((SCAC)) treatment retifanlimab, citing the need for more data.The Oncologic Drugs Advisory Committee ((ODAC)) voted 13-4 that a regulatory decision should be deferred until further data are available from clinical trial POD1UM-303, a confirmatory trial in platinum-naïve advanced SCAC that is currently underway.The BLA for retifanlimab is based on data from the mid-stage POD1UM-202 trial evaluating the drug in 94 previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, platinum-based chemotherapy.The FDA considers the advice of the ODAC in its review but is not bound to follow its recommendations.Retifanlimab had won the U.S. health regulator's "priority review" status, in January.

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FDA panel recommends deferring Incyte's retifanlimab BLA decision