The approval provides a new treatment option for patients with advanced, refractory melanoma who have limited alternatives after failure of standard immunotherapy. “For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited. Anti-PD-1 refractory melanoma is advanced skin cancer that no longer responds to a widely used class of immunotherapy drugs. The approval is granted under the FDA’s accelerated approval pathway based on objective response rate and duration of response. As a condition of accelerated approval, Replimune, Inc., is required to conduct post-approval trial(s) to verify and describe the clinical benefit of Tudriqev.