Replimune is resubmitting its twice-rejected melanoma drug after FDA leadership exodus

The FDA rejected vusolimogene oderparepvec twice under former Commissioner Marty Makary, who stepped down earlier this month

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Replimune Group announced plans to resubmit its application for its advanced melanoma treatment after reaching an agreement with the Food and Drug Administration on a path forward, following two prior rejections of the drug.

The company said it will resubmit the biologics license application for vusolimogene oderparepvec, also known as RP1, in the coming days. Both rejections centered on the same objection from regulators: the trial lacked a control group, leaving the FDA to insist on data from a properly controlled study before it would consider........

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