Replimune’s immunotherapy for advanced melanoma faced a perilous regulatory road with two previous rejections, but the drug—to be marketed as Tudriqev—prevailed with strong support from oncologists and a 10-3 advisory committee vote in its favor.
Replimune has prevailed at long last. ON Thursday, the FDA approved the biotech’s cancer immunotherapy in combination with Bristol Myers Squibb’s Opdivo for advanced melanoma—putting a bow on a long-running regulatory saga.
The drug with a storied history and many names: vusolimogene oderparepvec-wtpg, RP1, and now to be marketed as Tudriqev, won the FDA’s accelerated nod, in combination with Bristol Myers Squibb’s Opdivo, for adults with advanced melanoma who have experienced disease progression on an anti-PD-1 antibody-based regimen. The approval was granted based on objective response rate and duration of response, according to Replimune’s announcement late Thursday afternoon.
Continued marketing approval of Tudriqev “may be contingent on verification of clinical benefit in a confirmatory trial(s),” Replimune said.
“This is a transformative moment for Replimune, marking years of pioneering research to bring Tudriqev to patients desperately in need of new treatment options for advanced melanoma,” Replimune CEO Sushil Patel said in a prepared statement on Thursday.
The FDA in its statement similarly focused on the high unmet need in advanced melanoma.
“For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited. Clinicians managing these patients know this urgency firsthand,” said Karim Mikhail, acting director of the Center for Biologics Evaluation and Research, in a prepared statement. “Today’s important milestone gives oncologists a meaningful new tool — and more patients a fighting chance.”
Shares of Replimune were up nearly 9% to $12.86 when the market closed on Thursday.
An approval for Tudriqev was anything but certain. Last week, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC), voted 10-3 in support of the drug. The FDA is not obligated to follow the advice of advisory committees, though often does.
The advisors’ feedback was mixed, however—leaving the question of approval in doubt.
“This is messy data,” said Lawrence Schwartz, chair of the department of radiology at Memorial Sloan Kettering Cancer Center, who ultimately voted “yes,” during the meeting.
Several members of the committee said RP1 showed important efficacy signals but that criteria needed to be better established for decisions based on response evaluation criteria in solid tumors (RECIST) down the road.
Patient Representative Diane Aronson was one of those thrown by the data. Aronson, who voted no, called the RECIST criteria “confounding.”
RECIST was a primary concern for the FDA as well. In briefing documents released days before the adcomm, FDA reviewers said data from Replimune’s registrational trial were “not interpretable.”
The response assessment used in the Phase 1/2 IGNYTE study “confounds interpretation of the reported efficacy results and limits FDA’s ability to verify the reported results,” the reviewers added, laying out the agency’s seemingly definitive position.
In the IGNYTE trial, which comprised 140 patients, Tudriqev plus Opdivo elicited an objective response rate of 24.2%, with a median duration of response of 14.1 months. Tudriqev was “well tolerated with mostly mild-to-moderate adverse events,” according to Replimune.
The adcomm was scheduled so close to Replimune’s original FDA decision date of August 2, it raised the question of whether the agency would follow what appeared to be a predetermined position regardless of the committee’s vote.
Tudriqev has faced a challenging regulatory road. The engineered viral immunotherapeutic was first rebuffed by the FDA in July 2025, with reviewers writing in the CRL that they “would not recommend” seeking approval based on results from a single-arm study. The drug again failed to secure approval in April, with the FDA taking issue with the design of Replimune’s IGNYTE study.
Replimune’s adcomm on July 30 was part of a return to advisory committee meetings reportedly spearheaded by acting FDA Commissioner Kyle Diamantas after a 9-month drought. Moderna won approval on Wednesday for the mRNA-based flu vaccine mFLUVISA after an adcomm gave the shot its unanimous backing in June.
Capricor Therapeutics also endured an adcomm the day before Replimune’s for its cell therapy for Duchenne muscular dystrophy cardiomyopathy. Capricor did not fare as well, with advisors voting 9-3 against approval of deramiocel. Capricor is awaiting a decision on or before August 22.
The two adcomms were largely viewed in the biopharma industry as a bellwether, both for how the FDA would interact with its advisory committees, and for the rare disease space, which has recently enjoyed greater regulatory flexibility.
