FDA staff raise concerns over Replimune's skin cancer drug data

FDA staff have reiterated concerns that Replimune's investigational skin cancer therapy lacks sufficient data for approval.

The agency highlighted the single-arm trial, in which patients previously treated with a PD-1 inhibitor received Replimune's RP1 together with Opdivo, as inadequate to evaluate RP1's efficacy or systemic impact.

Briefing documents were released ahead of an upcoming advisory committee meeting, marking the biotech's third attempt to secure clearance for the locally injected treatment.