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3 clusters · 18 sources · 8 days · First seen · Last updated

Categories: HEALTH

Replimune melanoma therapy FDA approval

Entities: U.S. Food and Drug Administration · Tudriqev · Nivolumab · RP1 (vusolimogene oderparepvec) · Replimune

Overview

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, 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. The approval came after two earlier rejections that had criticized the 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, and a confirmatory late‑stage trial is ongoing. Analysts project peak U.S. sales of about $708 million by 2040. Tudriqev will compete with Iovance Biotherapeutics’ Amtagvi, approved earlier in 2024. Expert and patient‑advocate commentary highlighted the urgent need for effective therapies in this refractory melanoma population.

Timeline

  1. 3 days ago

    [HEALTH] 6 sources
    FDA approves new oncolytic viral therapy for anti‑PD‑1‑refractory melanoma

    FDA gives accelerated approval to RP1 (Tudriqev) with nivolumab for anti‑PD‑1‑refractory advanced melanoma, citing a 25% response rate and median 14‑month durability.

  2. 3 days ago

    [HEALTH] 4 sources
    US FDA Grants Approval to Replimune's Tudriqev for Advanced Melanoma

    The FDA approved Replimune’s Tudriqev (RP1) for advanced melanoma after two prior rejections, citing tumor‑shrinkage data and granting accelerated approval; sales could hit $708 M by 2040.

  3. 11 days ago

    [HEALTH] 11 sources
    FDA panel backs Replimune's RP1 melanoma therapy 10‑3

    FDA advisers voted 10‑3 to back Replimune’s RP1‑nivolumab data for advanced melanoma, despite earlier reviewer concerns. The non‑binding endorsement spurred a >100 % stock surge; FDA decision expected by Aug 2

Sources

aimatmelanoma.org · anh-usa.org · cancernetwork.com · collectionshub.com · es.qz.com · focoinformativo.com · gazeta.eu · lapatilla.com · newsable.asianetnews.com · pharmexec.com · sbctv.gr · statnews.com · stocktitan.net · thesheffieldpress.com · wdez.com · wsau.com · wtvbam.com · wxerfm.com

This summary has been updated 2 times: see revision history