FDA CBER director overrides review team to grant accelerated approval for Replimune's melanoma therapy Tudriqev

A senior official at the FDA's Center for Biologics Evaluation and Research stepped in to reverse a prior rejection by the agency's review panel. The director of the office of clinical evaluation approved an accelerated indication for Replimune's melanoma drug, Tudriqev, in early August.

The reversal means the therapy can now be marketed under the FDA's accelerated approval pathway, which allows earlier patient access based on surrogate endpoints. The decision was documented in internal FDA records that became public.

Replimune is expected to move forward with commercial preparations and further confirmatory studies, while the agency's move underscores the importance of the accelerated pathway for oncology treatments.