---
title: "FDA grants accelerated approval to Replimune’s RP1 (Tudriqev) for advanced melanoma"
id: "stat-news-0-stat-fda-approves-replimune-melanoma-drug-previously-rejected-twice"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-0-stat-fda-approves-replimune-melanoma-drug-previously-rejected-twice"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "STAT News"
source_url: "https://www.statnews.com/2026/08/06/replimune-melanoma-drug-rp1-fda-approves-phase-3-confirmatory-trial/?utm_campaign=rss"
published_at: "2026-08-06T19:59:28.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# FDA grants accelerated approval to Replimune’s RP1 (Tudriqev) for advanced melanoma
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-0-stat-fda-approves-replimune-melanoma-drug-previously-rejected-twice
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/2026/08/06/replimune-melanoma-drug-rp1-fda-approves-phase-3-confirmatory-trial/?utm_campaign=rss)
- **Published At:** 2026-08-06T19:59:28.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- The FDA has granted **accelerated approval** to Replimune’s oncolytic therapy **RP1**, which will be marketed as **Tudriqev**, for advanced melanoma, according to STAT. - The approval represents a reversal for Replimune after the drug had been rejected twice previously; the decision caps a contentious and closely watched regulatory saga. - An FDA advisory committee voted in support of the treatment prior to the approval, despite FDA staff raising concerns about the design and conduct of Replimune’s key clinical trial. - Advisers judged that there was a sufficient signal of efficacy and that patients with advanced melanoma face urgent treatment needs. - STAT reports that Replimune has not disclosed the planned price for Tudriqev. - The article was published by Elaine Chen on Aug. 6, 2026, and is presented as a STAT+ exclusive; much of the full story content is behind the STAT+ paywall and additional details were not reported in the publicly available portion of the source. - Specifics absent from the accessible article include detailed efficacy and safety data, the exact patient population for the approval, prescribing information, the FDA’s full rationale and labeling, and plans for confirmatory trials; these details were not reported in the source excerpt.
## Clinical Analysis & Structured Key Points
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[](https://www.linkedin.com/in/elaineywchen/ "Linkedin") 2. [](https://x.com/elaineywchen "X") elaine.chen@statnews.com Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes [The Readout newsletter](https://www.statnews.com/signup/readout/), and co-hosts STAT’s weekly biotech podcast, [The Readout Loud](https://www.statnews.com/category/readout-loud/). You can reach Elaine on Signal at elaineywchen.70. The Food and Drug Administration has cleared Replimune’s treatment for advanced melanoma, dealing the biotech a major win after a tumultuous saga of trying to seek approval for the controversial treatment. The FDA’s decision to grant accelerated approval to the drug, which is called RP1 and will be marketed as Tudriqev, came after its [advisers last week voted in support of the treatment](https://www.statnews.com/2026/07/30/replimune-melanoma-drug-rp1-fda-expert-meeting-live-blog/). Even though FDA staff expressed concerns about the design and conduct of Replimune’s key trial, advisers ultimately believed there was a large enough signal of efficacy and that patients are in urgent need of new treatments. Advertisement Replimune has not yet disclosed Tudriqev’s price. STAT+ Exclusive Story Already have an account? 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