The U.S. Food and Drug Administration (FDA) released briefing documents questioning the sufficiency of data supporting the company's treatment. The FDA reiterated that the company does not have adequate evidence to support approval, marking the third time Replimune has sought clearance for the therapy.
The FDA's concerns center on the design of Replimune's single-arm trial, in which patients who had previously been treated with a PD-1 inhibitor received the company's investigational drug RP1 in combination with Opdivo (nivolumab). The regulator argued that such a study is insufficient to evaluate the treatment's efficacy and whether the locally injected therapy produces systemic benefits.
The FDA also stated that 'there is no evidence that continued anti-PD-1 monotherapy provides any level of clinical benefit' in this context, further undermining the trial's rationale.
The briefing documents were released on Tuesday ahead of an advisory committee meeting scheduled for later that week.