Replimune Resubmits Melanoma Drug for FDA Approval After Initial Rejection
Replimune's RP1, a genetically modified HSV-1 oncolytic immunotherapy, was initially rejected by the FDA due to concerns over trial data.
The FDA has accepted a resubmission of the BLA for RP1 in combination with nivolumab for advanced melanoma.
The resubmission includes additional data and analyses addressing prior concerns, with a PDUFA date set for April 10, 2026.