Replimune's immunotherapy for advanced melanoma, RP1, has been backed by an FDA advisory committee, even though there was considerable debate about the design of a clinical trial used to support its marketing application. During the meeting, however, many panellists concluded that the efficacy signal in the data – and the pressing need for new treatment options in PD-1-refractory melanoma – meant that there was an argument for flexibility in assessing the data. "We are encouraged by today's outcome and would like to thank the committee for its thoughtful discussion of the IGNYTE data," said Sushil Patel, the company's chief executive. "This is an important step forward for patients with advanced melanoma who have progressed on anti-PD-1 therapy," he added. "We look forward to continuing to work with the FDA as it completes its review of the BLA ahead of the action date."