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Replimune melanoma therapy FDA approval

Updated 2 times since CLSTR started tracking revisions of this situation.

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2026-08-06 21:54 UTC → 2026-08-07 00:04 UTC · added removed

Following the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee vote of 10‑3 in late July 2026, the agency granted accelerated approval on 6 August 2026 to Replimune’s oncolytic herpes‑virus therapy RP1, now marketed as Tudriqev, for use with Bristol Myers Squibb’s Opdivo (nivolumab) in adults with unresectable or metastatic cutaneous melanoma that has progressed after prior anti‑PD‑1 treatment. The decision was based on data showing an objective response in roughly one‑quarter of patients, with responses lasting a median of about 14 months. Tudriqev works by injecting The approval came after two earlier rejections that had criticized the virus directly into tumors, single‑arm IGNYTE study for lacking a control group. The pivotal trial reported tumor shrinkage or disappearance in 24.2% of patients, with a median response duration of 14.1 months. RP1, also known as vusolimogene oderparepvec, is administered by direct intratumoral injection, where it lyses cancer cells and stimulates a systemic immune response. The FDA required post‑marketing studies to confirm clinical benefit. Analysts, noting the therapy’s relatively benign safety profile studies, and lack of comparable options in the PD‑1‑relapsed setting, a confirmatory late‑stage trial is ongoing. Analysts project peak U.S. sales of about $708 million by 2040. The product Tudriqev will compete with Iovance Biotherapeutics’ Amtagvi, which relies on surgical tumor harvesting. approved earlier in 2024. Expert and patient‑advocate commentary highlighted the urgent need for effective treatments therapies in this refractory melanoma population.

Versions

  1. 2026-08-07 00:04 UTC Replimune melanoma therapy FDA approval
  2. 2026-08-06 21:54 UTC Replimune melanoma therapy FDA approval
  3. 2026-08-06 21:32 UTC Replimune melanoma therapy FDA approval

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