Replimune's melanoma drug clears FDA panel after two prior rejections

Melanoma patients may gain access to a new treatment option if FDA grants final approval following the panel's recommendation.

After two regulatory rejections, Replimune's oncolytic immunotherapy for advanced melanoma has received the endorsement of an FDA advisory committee — a moment that speaks to the slow, contested nature of medical progress and the weight carried by patients who have run out of options. The panel voted favorably even while acknowledging imperfections in the trial design, suggesting that the human need for new tools against a relentless disease can, at times, tip the scales of scientific caution. The final decision now rests with the FDA itself, and with it, the question of whether a novel approa

Replimune's melanoma drug clears FDA panel after two prior rejections

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