FDA Staff Unconvinced Drug for Melanoma Shows Benefit

— Replimune's RP1 faces tough test at upcoming FDA advisory panel meeting

July 28, 2026

• 3 min read

Another attempt to win accelerated approval for RP1 (vusolimogene oderparepvec) -- a melanoma drug candidate that's already been rejected twice by the FDA -- could face tough going at a meeting of FDA's outside experts this week.

In a briefing document published in advance of Thursday's meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee, FDA staff wrote that the phase II single-arm IGNYTE study -- submitted by Replimune to support accelerated approval of RP1 in combination with nivolumab (Opdivo) for the treatment of advanced melanoma -- was not "an adequate and well-controlled investigation that demonstrates substantial evidence of effectiveness."

FDA Staff Unconvinced Drug for Melanoma Shows Benefit

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