Replimune secures FDA accelerated approval for melanoma therapy Tudriqev

Replimune announced that the FDA has granted accelerated approval to its melanoma therapy RP1, marketed as Tudriqev, after two earlier rejections and a third expedited review. The decision reflects a more flexible regulatory stance on cancer drugs, though FDA staff still voiced concerns about the data supporting the therapy.

The company set the list price at $450,000 per treatment course before any rebates or discounts. Replimune expects strong demand, citing the regimen’s relative ease of administration and a benign safety profile.

The approval was highlighted alongside other biotech developments, including shifting biotech activity from Boston to California and new insights into tau’s role in Alzheimer’s disease.