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# FDA Panel Backs Replimune Melanoma Therapy
- URL: https://www.fdaweb.com/fda-panel-backs-replimune-melanoma-therapy/
- Published: 2026-07-30T12:00:00.000Z
- Updated: 2026-09-14T13:44:05.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161555

FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee has voted 10 to 3 to recommend approval of Replimune's experimental oncolytic immunotherapy RP1 (vusolimogene oderparepvec) in combination with Bristol Myers Squibb's Opdivo for patients with advanced melanoma, despite FDA reviewers' conclusions that the application lacked adequate evidence of effectiveness. The committee found that the therapy's potential benefits outweighed concerns over the strength of the supporting clinical data.

In briefing documents ([see earlier story](https://www.fdaweb.com/reviewers-concerned-about-data-supporting-replimune-melanoma-bla/)) released before the panel meeting, FDA reviewers had argued that the company’s BLA relied on a single-arm trial without an adequate control group, making it impossible to determine the contribution of RP1 to the responses observed with the combination regimen. Agency staff also questioned aspects of the trial's response assessment, saying they may have artificially inflated efficacy results.

During the panel meeting, committee members acknowledged the limitations of the data package but also cited the lack of effective treatment options for patients with anti-PD-1 refractory melanoma. Supporters of the therapy argued that the durable responses observed in heavily pretreated patients and the unmet medical need justified approval despite the uncertainties surrounding the trial design.

The favorable panel endorsement is the latest action in the therapy’s regulatory history, which includes two previous FDA rejections. A June BLA resubmission followed FDA's April complete response letter, with the agency declining to approve RP1 despite clinical trial results showing tumor shrinkage or disappearance in roughly one-third of patients. The decision, together with several other high-profile regulatory setbacks issued this spring, drew criticism from industry groups and investors, who argued the agency had become less predictable under former FDA commissioner **Marty Makary** and the Trump administration. ([see earlier story](https://www.fdaweb.com/critics-pile-on-makarys-ouster-with-melanoma-drug-denial/)).

The agency reportedly had previously warned Replimune that its single-arm trial design could jeopardize approval. Still, the decision drew heightened scrutiny because it occurred amid internal upheaval at FDA during Makary’s tenure. Makary publicly defended the rejection and accused Replimune of engaging in “corporate spin” after criticism emerged following the decision.

RP1 is a genetically engineered virus designed to destroy tumor cells and stimulate immune activity alongside the immunotherapy drug Opdivo.