An FDA advisory panel voted on July 30 to support trial results for Replimune's investigational agent RP1 used with Bristol Myers Squibb's Opdivo to treat advanced melanoma. The FDA had declined approval in April, citing reliance on a single-arm study and asking for data from a well-controlled trial. The panel's endorsement is influential but non-binding; the FDA will make the final decision.
FDA Advisory Panel Backs Replimune RP1 Trial Data for Advanced Melanoma
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
On July 30, a committee of external advisers to the U.S. Food and Drug Administration voted to endorse the findings from a trial evaluating Replimune's investigational therapy RP1 for a form of skin cancer.
Panel Vote And Regulatory Context
The advisory panel's backing comes after the FDA declined to approve the therapy in April, saying the submission relied on a single-arm study without a control group and requesting data from a well-controlled trial to establish clear evidence of effectiveness. The agency had also rejected an earlier application from Replimune last year.
What Replimune Is Seeking
Replimune is pursuing approval for RP1 to be used in combination with Bristol Myers Squibb's immunotherapy Opdivo (nivolumab) for the treatment of advanced melanoma — an especially aggressive form of skin cancer. The advisory panel's vote supports the trial results but is non-binding; the FDA makes the final approval decision.
Why This Matters
Advisory panels provide outside expert input that can influence regulators' decisions and timeline for further studies or approvals. The FDA's request for a well-controlled trial reflects a higher standard of evidence intended to confirm whether the combination delivers meaningful clinical benefit beyond what a single-arm study can demonstrate.
Reporting by Puyaan Singh in Bengaluru; Editing by Shailesh Kuber.
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