FDA approves Tudriqev for advanced melanoma after earlier rejections

FDA granted accelerated approval to Tudriqev on August 6 in combination with nivolumab for certain patients with unresectable advanced melanoma whose disease progressed after PD 1 treatment. Tudriqev is an engineered oncolytic virus that is injected into tumors and intended to destroy cancer cells while stimulating an immune response.

The approval was based on 91 evaluable patients in a single arm study. Twenty four percent responded, and the median duration of response was 14.1 months. The study did not include a randomized control group, and Replimune must verify the benefit in a confirmatory phase 3 trial.

Results from the supporting study

The efficacy analysis included 91 patients whose melanoma had progressed after prior PD 1 therapy. Twenty two patients had a confirmed response, producing an objective response rate of 24 percent. The median duration of response was 14.1 months.

Because the trial did not include a control group, it did not directly compare Tudriqev and nivolumab with another treatment. FDA used the accelerated approval pathway, which permits earlier approval based on a measure considered reasonably likely to predict clinical benefit.

FDA had previously rejected the application

The approval followed two earlier FDA rejections. Agency reviewers had questioned whether the single arm study was sufficient to determine the treatment's effect and whether differences among enrolled patients could have influenced the result.

Outside advisers and patient representatives argued that the duration of some responses and the limited options available after PD 1 treatment supported access. FDA cited input from patients and clinical experts when announcing the approval.

A phase 3 trial must confirm the benefit

Replimune must complete a randomized phase 3 trial to confirm that the combination provides clinical benefit. The company has said results from that study are expected in late 2027.

Continued approval may depend on the outcome. FDA can require labeling changes or seek withdrawal if the confirmatory study does not verify benefit or if the sponsor fails to complete it with appropriate diligence.