Junshi Biosciences’ Mucosal Melanoma Treatment Nabs FDA Fast-Track Status

The FDA has granted Junshi Biosciences a Fast-Track designation for toripalimab as a first-line treatment for mucosal melanoma.

The agency has also cleared the monoclonal antibody for a phase 3 trial in combination with axitinib as a first-line treatment for patients suffering from advanced mucosal melanoma.

Toripalimab received a Breakthrough Therapy designation from the FDA in September for treating metastatic nasopharyngeal carcinoma.