By Xavier Martinez, August 6th, 2026 | From: The Wall Street Journal

Replimune Group said Thursday that the Food and Drug Administration has approved its therapy for advanced skin cancer, ending a regulatory saga that spanned three submissions and two rejections and was a flashpoint in the tenure of the agency’s last commissioner.

Replimune’s drug, marketed as Tudriqev, is a genetically modified virus that doctors inject directly into tumors, where it is designed to kill cancer cells and trigger an immune response against tumors elsewhere in the body.

The drug’s arduous journey through the FDA made it a poster child for the biotech industry’s criticism of the agency under former Commissioner Marty Makary. Replimune and other industry officials said the FDA, in its rejections, had reversed positions it had established in earlier meetings with the company.

Advisory committee ​votes in favor of ​Replimune's drugReplimune says ​the FDA will ​do a third reviewFDA rejects ​Tudriqev a​second timeFDA reviews ​Replimune's ​second submissionSept. 2025'26-100-75-50-250255075100125150%

Replimune first submitted its application for the therapy in November 2024. The FDA rejected it in July of last year and rejected a resubmission in April. Regulators said they couldn’t tell how much of the drug’s effect came from Tudriqev itself—rather than the medication it was tested with in a combination therapy. The study didn’t have a placebo arm, either.

While still head of the agency, Makary publicly defended the rejections of Replimune’s medication. “If your drug works, it’s going to get approved,” he said in May.

Ultimately, the White House pushed public health officials to re-examine the FDA’s repeated rejections of the Replimune drug, The Wall Street Journal reported.

After Makary left the agency, Replimune said it had reached an agreement with the FDA to try a third time. Replimune resubmitted its application in June, and the FDA agreed to conduct its review on an expedited timeline.

An FDA advisory committee weighed in last week, voting 10 to 3 that Replimune’s trial results were clinically meaningful. In the trial, about one-quarter of patients responded to treatment, which lasted a median of 14 months. Panelists who voted no said the lack of a placebo meant the trial didn’t meet their bar, whatever the drug’s apparent benefit.

As a condition of accelerated approval, Replimune is required to conduct a follow-up trial to confirm Tudriqev’s safety and effectiveness.  

Tudriqev is the second FDA-approved option for melanoma patients who have stopped responding to immunotherapy drugs, after Iovance Biotherapeutics’ Amtagvi, a cell therapy cleared in 2024. Amtagvi’s sales were $220 million last year. 

Replimune, based outside Boston, will market the new drug alongside Bristol-Myers Squibb’s Opdivo for patients whose melanoma has progressed after immunotherapy alone has failed.

Roughly half of advanced melanoma patients’ diseases eventually progress while taking immunotherapies like Opdivo and Merck’s Keytruda.

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Appeared in the August 7, 2026, print edition as 'Melanoma Drug Gets Approval From FDA'.