FDA panel backs Replimune's RP1 melanoma therapy 10‑3
The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee voted 10‑3 to deem the efficacy data from Replimune Group Inc.’s RP1 (vusolimogene oderparepvec) combined with nivolumab as clinically meaningful for adults with advanced melanoma who have progressed after anti‑PD‑1 therapy. The vote concerns the single‑arm IGNYTE phase 1/2 trial, which reviewers said makes it difficult to verify how much benefit derives from RP1 versus the partner drug. While the advisory committee’s recommendation is non‑binding, it strengthens the resubmitted Biologics License Application (BLA 125827) and moves the agency toward a target action date of 2 August 2026.
The panel’s support follows earlier FDA staff concerns that the trial design did not provide an adequate, well‑controlled investigation. The regulatory win triggered a sharp market reaction: Replimune shares more than doubled in pre‑market trading, rising 120‑130 % in some reports and up 127 % after hours. The company previously received Breakthrough Therapy Designation and Priority Review for RP1, and it is seeking accelerated approval for the combination therapy.
Entities: Advanced melanoma patients · IGNYTE study · IGNYTE trial · Nivolumab · Nivolumab (Opdivo) · RP1 (vusolimogene odereparvovec) · RP1 (vusolimogene oderparepvec) · RP1 (vusolimogene oderparevvec) · Replimune Group Inc. · Replimune Inc. · U.S. Food and Drug Administration · U.S. Food and Drug Administration (FDA)
Claims
What the coverage asserts, and how well corroborated each claim is across sources.
- [● 7 SOURCES] The FDA has set a target action date of 2 August 2026 for the RP1 BLA review. (supporting_article_ids)
- [● 2 SOURCES] RP1 (vusolimogene oderparevvec) is an oncolytic immunotherapy built from a modified herpes‑simplex virus and injected directly into tumors. (b69343df-78b0-4ad2-bcae-c75c78f19741)
- [○ 1 SOURCE] The FDA advisory committee voted 10‑3 that RP1 efficacy results are evaluable and clinically meaningful. (b8bd1fc8-8890-4679-92fd-4ef99b22ec6a)
- [● 2 SOURCES] Replimune’s shares fell roughly 30 percent after FDA reviewers raised concerns about RP1 trial data. (b69343df-78b0-4ad2-bcae-c75c78f19741)
- [○ 1 SOURCE] The IGNYTE trial of RP1 was a single‑arm study without a control group, limiting attribution of benefit to RP1. (b69343df-78b0-4ad2-bcae-c75c78f19741)
- [○ 1 SOURCE] RP1 previously received FDA Breakthrough Therapy Designation and Priority Review. (supporting_article_ids)
- [● 2 SOURCES] FDA reviewers said they could not verify the central efficacy results of the RP1 trial because the study design confounds interpretation. (supporting_article_ids)
- [● 6 SOURCES] Replimune’s share price more than doubled, rising about 120‑130 % in pre‑market trading after the advisory vote. (supporting_article_ids)
- [● 3 SOURCES] The advisory committee’s recommendation is non‑binding and does not constitute FDA approval. (supporting_article_ids)
- [● 7 SOURCES] The FDA advisory committee voted 10‑3 in favor of RP1 efficacy data. (supporting_article_ids)
- [● 4 SOURCES] RP1 (vusolimogene oderparepvec) is administered together with nivolumab for advanced melanoma patients who progressed after anti‑PD‑1 therapy. (supporting_article_ids)
- [● 4 SOURCES] The IGNYTE trial evaluated RP1 plus nivolumab in a single‑arm phase 1/2 study without a control group. (supporting_article_ids)