FDA approves Replimune's Tudriqev for advanced melanoma after two rejections

Tudriqev becomes second option for melanoma after immunotherapy fails

Replimune Group said Thursday that the U.S. Food and Drug Administration approved Tudriqev, the company’s therapy for advanced melanoma, following two previous rejections and a third submission the agency reviewed on an expedited timeline. The drug 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 approval followed a process involving three submissions and two rejections. The case became a point of criticism for the biotech industry. Replimune and other industry officials said the FDA, in its rejections, had reversed positions it had established in earlier meetings with the company.

Replimune first submitted its application for the therapy in November 2024. The FDA rejected it in July 2025 and rejected a resubmission in April. Regulators said they could not tell how much of the drug’s effect came from Tudriqev itself rather than the medication it was tested with in a combination therapy, and the study did not have a placebo arm.

While still head of the agency, Makary publicly defended the rejections. “If your drug works, it’s going to get approved,” he said in May. The Wall Street Journal reported that the White House pushed public health officials to re-examine the FDA’s repeated rejections of the Replimune drug.

After Makary left the agency, Replimune said it had reached an agreement with the FDA to try a third time. The company 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, with responses lasting a median of 14 months. Panelists who voted no said the lack of a placebo meant the trial did not 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.