Back on Track: US FDA Accepts BLA Resubmission of RP1 for the Treatment of Advanced Melanoma; New PDUFA Date Set
The US Food and Drug Administration (FDA) has accepted the resubmission of Replimune Group, Inc.’s Biologics License Application (BLA) for RP1 in combination with nivolumab (Opdivo, Bristol Myers Squibb) for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen.