24-07-2025
FDA Declines to Approve New Melanoma Therapy
The FDA has declined to approve a new oncolytic immunotherapy, vusolimogene oderparepvec (RP1), to treat advanced melanoma.
The agency recently issued a complete response letter to the company, Replimune Group, rejecting its biologics license application that sought approval for the new agent in combination with nivolumab (Opdivo) to treat adults with advanced melanoma.
In the complete response letter, the FDA indicated that it can't approve the biologics license application for vusolimogene oderparepvec because the company's IGNYTE trial 'is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness,' Replimune explained in a press release.
According to Replimune, the complete response letter also noted that the trial data 'cannot be adequately interpreted due to the heterogeneity of the patient population,' and that 'there are items related to the confirmatory trial study design which need to be addressed.'
'We are surprised by the FDA decision and disappointed for advanced melanoma patients who have limited treatment options, as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data,' stated Sushil Patel, PhD, Replimune's chief executive officer. Vusolimogene oderparepvec is the lead product candidate for the biotech company.
Patel further noted that the issues raised in the complete response letter were not 'raised by the agency in mid- and late-cycle reviews.' Additionally, he said, 'we had also aligned on the design of the confirmatory study.'
The FDA's response to the biologics license application for the new agent, along with its recently announced policy requiring randomized, controlled trials for approval of COVID vaccines in healthy Americans younger than 65 years, may signal that the agency is taking a tougher stance on new drug approvals.
Replimune plans to 'urgently interact with the FDA to find a path forward for the timely accelerated approval of RP1,' according to its statement.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape Medical News, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@ or on X @SW_MedReporter.
