FDA points full response letter to Replimune’s RP1
The U.S. Meals and Drug Administration (FDA) has issued an entire response letter (CRL) to Replimune Group’s biologics license utility (BLA) relating to RP1 remedy together with nivolumab for superior melanoma.
The choice impacts Replimune’s lead product candidate, which relies on a genetically engineered herpes simplex virus meant to stimulate an anti-tumor immune response.
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Within the IGNYTE research, sufferers handled with RP1 plus nivolumab confirmed a response fee of 34% and a median period of 24.8 months, with a good security profile.
Replimune claims that these outcomes justify making the remedy accessible to most cancers sufferers with superior levels of the illness.
The corporate famous that the FDA indicated a change within the evaluate group concerned within the resubmission, a choice that differed from the September 2025 Kind A gathering discussions.
Replimune CEO Sushil Patel mentioned: “It is vitally disappointing that the FDA has not exercised regulatory flexibility to fulfill affected person wants given the info supporting its sturdy efficacy and favorable security profile.
“As we now have beforehand communicated, with out well timed, accelerated approval, growth of RP1 won’t be viable. We’re devastated for our devoted workers who’ve labored tirelessly on behalf of sufferers, however right now we now have no alternative however to chop jobs, together with considerably scaling again our U.S.-based manufacturing operations.”
Replimune beforehand supplied a proposal with descriptive evaluation of IGNYTE-3, supporting the elements’ contributions. It additionally included knowledge from IGNYTE that indicated a median progression-free survival of 30.6 months on RP1 with nivolumab, in comparison with 4.4 months on earlier therapies.
The corporate sought suggestions; Nonetheless, the FDA didn’t reply and subsequently thought of the resubmission as an entire response to the July 2025 CRL.
Points had been raised by the company relating to tumor evaluation methods, with Replimune adhering to the FDA’s request to make use of the RECIST 1.1 requirements as is. The corporate submitted in depth analyzes exhibiting constant response charges no matter lesion remedy and confirmed that biopsies didn’t have an effect on tumor response.
Earlier than submitting the unique BLA, Replimune engaged in regulatory discussions relating to trial design and affected person standards.
Though the usual protocol requires a randomized managed trial, Kind B minutes from March 2021 revealed ideas from the FDA that compelling knowledge may justify consideration via an accelerated approval pathway.
