Anchor
FDA weighs Replimune's melanoma immunotherapy RP1
Rule ChangesThe FDA granted accelerated approval on August 6, four days after its deadline, following a 10-3 advisory panel vote backing the trial data
August 6th, 2026: Replimune prices Tudriqev at $450,000, plans launch within 60 daysNew here? Follow stories to track developments over time. Create a free account to get updates when stories you care about change.
Overview
The FDA granted accelerated approval on August 6 to Replimune's tumor-injected virus therapy, now sold as Tudriqev, after rejecting it twice. An advisory panel had voted 10-3 on July 30 that the trial data were reliable enough to support approval, despite FDA staff's earlier doubts.
About a quarter of patients responded to Tudriqev plus nivolumab, with responses lasting a median of 14.1 months. Replimune priced a full course at $450,000 and plans to launch within about 60 days, but the approval stays conditional on a confirmatory trial due to report in 2030.
Why it matters
Patients with treatment-resistant melanoma gain a new $450,000 option, but its future depends on a 2030 trial readout.
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Key Indicators
24.2%
Tumor response rate (ORR)
Share of efficacy-evaluable IGNYTE trial patients whose tumors shrank on Tudriqev plus nivolumab, per the FDA-approved label.
14.1 months
Median duration of response
How long tumor shrinkage lasted, on average, for patients who responded, per the FDA label.
$450,000
List price per treatment course
Replimune's list price for a full course of Tudriqev, based on the median dose given in its pivotal trial.
Aug 6, 2026
FDA accelerated approval date
The date the FDA cleared Tudriqev plus nivolumab, four days after its original decision deadline.
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FDA weighs Replimune's melanoma immunotherapy RP1
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People Involved
Organizations Involved
Replimune Group
Biotechnology company
Won FDA accelerated approval for Tudriqev on August 6 and is preparing a commercial launch within about 60 days.
A Massachusetts biotech developing tumor-injected virus therapies for cancer.
FDA Cellular, Tissue, and Gene Therapies Advisory Committee
Federal advisory panel
Voted 10-3 on July 30 that RP1's trial data were evaluable, a recommendation the FDA followed six days later.
An outside panel of experts that advises the FDA on cell and gene therapy products.
Timeline
January 2025 August 2026
7 events
Latest: August 6th, 2026 · 1 week ago
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-
Replimune prices Tudriqev at $450,000, plans launch within 60 days
Latest BusinessShares jumped and analysts including Wedbush and BMO Capital raised price targets after approval. Replimune set a list price near $450,000 per course and said it expects to launch within about 60 days.
-
Advisory panel votes on RP1's evidence
Advisory VoteThe FDA's Cellular, Tissue, and Gene Therapies Advisory Committee meets to vote on whether the data reliably support approval of RP1 plus nivolumab. The vote is advice, not a final ruling.
-
FDA briefing documents call the data uninterpretable
StatementFDA staff publish concerns that the trial cannot separate RP1's effect from nivolumab's or from patient differences. Replimune shares fall about 30% in a day.
-
FDA accepts a third resubmission
RegulatoryThe agency takes up the application again and sets a fresh decision date of August 2, 2026, and signals an advisory committee meeting.
-
FDA accepts a resubmission
RegulatoryReplimune refiles and the FDA sets a new decision date of April 10, 2026, under a standard resubmission timeline.
-
FDA rejects the first application
LegalThe agency issues a Complete Response Letter, saying the single-arm IGNYTE trial is not adequate and well-controlled and cannot be interpreted because patients differed too much. No safety problems are raised.
-
FDA accepts RP1 filing with priority review
RegulatoryThe FDA takes up Replimune's application for RP1 plus nivolumab and sets a decision date of July 22, 2025. The drug carries breakthrough therapy designation.
Historical Context
3 moments from history that rhyme with this story — and how they unfolded.
October 2015
T-VEC (Imlygic) approval (2015)
The FDA approved talimogene laherparepvec, the first oncolytic virus therapy, for melanoma lesions in the skin and lymph nodes. Robert Coffin, who later founded Replimune, developed it. An advisory panel had backed it 22-1.
Then
Doctors gained a virus injected directly into melanoma tumors, though its effect on survival was modest.
Now
It proved oncolytic viruses could reach market and set the scientific template Replimune built RP1 on.
Why this matters now
RP1 is the next-generation version of the same idea, from the same scientist. It shows the approach can win approval, but also that the FDA scrutinizes how much the virus itself adds.
April 2023
Covis Therapeutics' Makena withdrawal (2023)
The FDA pulled the preterm-birth drug Makena after a confirmatory trial failed to show benefit. It had reached market through accelerated approval based on weaker early data years earlier.
Then
The drug came off the market and patients lost access.
Now
The case hardened FDA insistence that accelerated approvals rest on trials that can actually confirm benefit.
Why this matters now
It explains why FDA reviewers press Replimune on the missing control arm. The agency has been burned when single-arm data did not hold up.
March 2007 to April 2010
Provenge (sipuleucel-T) advisory fight (2007-2010)
An FDA panel backed Dendreon's prostate cancer immunotherapy, but the agency demanded more data and delayed approval. Provenge finally cleared in 2010 after a survival trial.
Then
Patients and investors endured a three-year limbo while the company ran more trials.
Now
The drug reached market but struggled commercially, and Dendreon later went bankrupt.
Why this matters now
It shows how a novel immunotherapy can survive FDA doubts yet face a long, costly path, a plausible outcome for RP1 if approval slips to the confirmatory trial.
Sources
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