FDA ‘Fast Tracks’ Toripalimab in Frontline Mucosal Melanoma

Source: Targeted Oncology, January 2021

The FDA granted a Fast Track designation (FTD) to the humanized PD-1 monoclonal antibody toripalimab for the first-line treatment of patients with mucosal melanoma, announced Junshi Biosciences, in a press release.1

The agent, which is manufactured in China, has already received a Breakthrough Therapy designation from the FDA as a treatment for recurrent/metastatic nasopharyngeal carcinoma.

Receipt of an FTD designation from the FDA will advance the development of toripalimab in the mucosal melanoma setting.

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