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The FDA has granted accelerated approval to vusolimogene oderparepvec (Tudriqev, Replimune) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma after progression on an anti-PD-1-based regimen.
The approval follows a July 30 FDA advisory committee vote of 10-3 that the available data from the IGNYTE trial were evaluable and demonstrated clinically meaningful benefit. The agency had previously declined to approve the treatment twice, citing concerns about the single-arm IGNYTE trial and the lack of a control group.
Vusolimogene oderparepvec (RP1) is a genetically modified herpes simplex virus that is injected directly into tumors, leading to cell lysis and antitumor immune activation, which may restore response to PD-1 blockade.
Approval was based on the single-arm IGNYTE trial in 140 patients with stage IIIB, IIIC, or IV unresectable advanced melanoma whose disease progressed after at least 8 weeks of PD-1 blockade.
Among 91 patients evaluated for efficacy, the objective response rate was 24.2% and the median duration of response was 14.1 months.
The labeling contains warnings and precautions for accidental exposure, herpetic infection or reactivation, injection procedure complications, and immune-mediated events.
Serious adverse reactions occurred in 35% of patients. The most common adverse reactions included fatigue, pyrexia, infection, chills, musculoskeletal pain, and nausea.
The list price of RP1 will be $450,000 per course of therapy, the company said.
The FDA's accelerated approval is based on objective response rate and duration of response, with continued approval contingent on verification of clinical benefit in confirmatory trial(s), according to an FDA press release.
M. Alexander Otto is a physician assistant and award-winning journalist. He is also an MIT science journalism fellow. Email: aotto@medscape.net
