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# Replimune to Refile Controversial Melanoma BLA
- URL: https://www.fdaweb.com/replimune-to-refile-controversial-melanoma-bla/
- Published: 2026-05-29T12:00:00.000Z
- Updated: 2026-09-14T13:40:10.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161227

Replimune plans to resubmit for the third time its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment for advanced melanoma following what the company described as productive discussions with the agency. It says FDA had aligned with Replimune on a path forward for reconsideration of the application for RP1, and indicated it would prioritize review of the resubmission because of the unmet medical need in patients with advanced melanoma who have progressed after anti-PD-1 therapy.

Replimune says it expects to resubmit the application “in the coming days.”

FDA’s April rejection of the experimental melanoma treatment had become a flashpoint in broader criticism of former FDA commissioner **Marty Makary** and the agency’s increasingly unpredictable regulatory climate under the Trump administration ([see earlier story](https://www.fdaweb.com/critics-pile-on-makarys-ouster-with-melanoma-drug-denial/)). The agency declined to approve RP1 despite clinical trial results showing tumor shrinkage or disappearance in roughly one-third of patients.

Doctors involved in the study said the decision devastated patients and researchers who viewed the treatment as potentially life-saving for advanced melanoma patients with limited options. “

RP1 is a genetically engineered virus designed to destroy tumor cells and stimulate immune activity alongside the immunotherapy drug Opdivo. FDA said it was not convinced the positive outcomes could be fully attributed to RP1 because the trial lacked a control arm comparing the treatment against standard therapy alone.

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.

FDA has been facing rowing criticism from industry groups and former regulators over what they describe as conflicting signals on drug approval standards, particularly for cancer therapies, vaccines and accelerated approval programs.