Senior FDA official overrides reviewers to grant Replimune accelerated approval for melanoma drug Tudriqev

FDA's primary review team recommended rejecting Replimune's melanoma therapy Tudriqev, saying the company had not adequately addressed key deficiencies noted in earlier complete response letters.

A senior director at the Center for Biologics Evaluation and Research overruled the reviewers and granted the drug accelerated approval.

The therapy had previously been denied in July 2025 and again in April, and an advisory committee had voted 10-3 to support approval despite concerns that the data were messy.

The episode underscores the tension between review teams and senior officials and the challenges of meeting FDA evidentiary standards for advanced melanoma treatments.