Signal FDA grants accelerated approval to Replimune's Tudriqev for advanced melanoma

Summary

The US FDA granted accelerated approval to Replimune's Tudriqev, also known as RP1, in combination with nivolumab. The approval covers adult patients with unresectable advanced cutaneous melanoma whose disease progressed after anti-PD-1 based therapy. Tudriqev had previously received Breakthrough Therapy designation from the FDA. It also received Priority Review designation. Specific trial response-rate or survival figures were not detailed in the source report. The approval adds a new treatment option for this patient population.