After rejecting Replimune’s melanoma drug RP1 this summer, the FDA has accepted the biotech’s resubmission of an approval application.
The federal agency said it expects to reach a decision on or by April 10, 2026, according to an Oct. 20 release from Replimune.
The freshly submitted biologics license application centers on Replimune’s lead candidate RP1, an engineered strain of the herpes simplex virus delivered in combination with Bristol Myers Squibb’s checkpoint inhibitor Opdivo. The asset is designed to kill cancer cells and turn the immune system against the tumor.
Replimune requested FDA approval of the cancer drug based on findings from a phase 1/2 trial that included 140 patients who had previously progressed on a PD-1 drug. The study had recorded an objective response rate of 32.9%.
However, the FDA found fault with Replimune’s study and delivered a high-profile rejection back in July. The agency said the trial wasn’t able to be “adequately interpreted due to the heterogeneity of the patient population,” according to a release from the biotech.
The agency snub received widespread public criticism, with the editorial board at The Wall Street Journal even responding to the decision with a scathing opinion piece that claimed “therapies for rare and deadly disease are dying in Marty Makary’s shop.”
Now, Replimune has added “information, data and analyses” to the resubmission, according to the company.
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Replimune looks forward to “working closely with the agency to expedite this review as much as possible for patients’ benefit,” the biotech’s CEO, Sushil Patel, Ph.D., said in the Oct. 20 release.
“RP1 plus nivolumab offers a strong risk benefit profile where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy,” the Replimune CEO added.
The biotech’s stock was up nearly 100% at market close, resting at $8.94 per share at the end of the day.
