FDA Fast Track of Novel Agent May Lead to an Accelerated Approval of Skin Cancer Treatment


The FDA’s fast track designation for toripalimab to treat patients with mucosal melanoma may lead to an accelerated approval of the novel therapy.

The Food and Drug Administration (FDA) has granted fast track designation to toripalimab, an anti-PD-1 monoclonal antibody, for the firstline treatment of patients with mucosal melanoma, according to the agent’s manufacturer, Junshi Biosciences.

The agency grants fast track designation “to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need,” according to its website. This designation has the potential to lead to an accelerated approval for a drug.

Toripalimab is approved for marketing in China and more than 30 company-sponsored trials have investigated its use across 15 indications around the world.

The agency also approved a new drug application for a phase 3 trial that is expected to assess the safety and efficacy of toripalimab in combination with Inlyta (axitinib) in the firstline treatment of 220 patients with unresectable, locally advanced or metastatic mucosal melanoma, compared to Keytruda (pembrolizumab).

Participants are expected to be randomized 1:1 to receive either the combination of toripalimab and Inlyta or Keytruda. Measuring progression-free survival (length of time during and after the treatment of disease that a patient lives without the disease getting worse) is expected to serve as the main goal of the study. Other goals of the study are to measure objective responses (partial or complete responses to treatment), duration of response, overall survival and safety.

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