The US Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy developed by Replimune, for the treatment of advanced, refractory melanoma.
Tudriqev is approved for use in combination with nivolumab to treat adults with unresectable advanced cutaneous melanoma whose disease has progressed despite treatment with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
“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,” said Sushil Patel, CEO of Replimune.
The approval is based on clinical trial data showing that one in four patients responded to the TUDRIQEV plus nivolumab therapy, with responses lasting a median of nearly 14 months. The FDA also considered feedback from clinical experts and patient advocates, who highlighted the significant unmet need for patients with PD-1-refractory 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 (CBER).
“Today’s important milestone gives oncologists a meaningful new tool — and more patients a fighting chance,” he added.
How the drug works
Anti-PD-1 refractory melanoma refers to advanced skin cancer that no longer responds to a commonly used class of immunotherapy drugs. In these patients, the tumour develops mechanisms to evade the immune system’s ability to detect and destroy it, allowing the disease to continue progressing despite treatment.
Tudriqev is an oncolytic viral therapy derived from a modified herpes simplex virus type 1 (HSV-1) that is engineered to selectively target and destroy cancer cells. Once injected into a tumour, the virus replicates and breaks cancer cells apart while also triggering the body’s immune system to recognize and attack the cancer. In combination with the anti-PD-1 immunotherapy nivolumab, Tudriqev is intended to help restore anti-tumour immune responses in patients whose melanoma has become resistant to prior immunotherapy.
According to FDA, the therapy is administered by direct injection into tumours every two weeks for eight consecutive doses, with the dose determined by tumour size. A lower concentration is used for the first dose, followed by a higher concentration for all subsequent doses. Intravenous nivolumab is initiated during the third week of treatment.
“For patients with advanced melanoma who have exhausted immunotherapy options, today’s approval offers a meaningful new path forward — grounded in early evidence and backed by the accountability that accelerated approval demands,” said Megha Kaushal, Acting Deputy Director of the CBER Office of Therapeutic Products.
Under the accelerated approval pathway, Replimune must conduct post-marketing studies to confirm the treatment’s clinical benefit. Continued approval will depend on the results of these confirmatory trials.
Replimune said a confirmatory Phase 3 study, IGNYTE-3, is currently underway to evaluate Tudriqev in combination with nivolumab.
