FDA grants fast track designation to toripalimab for mucosal melanoma
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The FDA granted fast track designation to toripalimab for the first-line treatment of patients with mucosal melanoma, according to a manufacturer-issued press release.
Toripalimab (Junshi Biosciences) is an anti-PD-1 monoclonal antibody.
The FDA also approved an investigational new drug application for the international, multicenter, randomized phase 3 combination trial of first-line toripalimab plus axitinib (Inlyta, Pfizer) compared with pembrolizumab (Keytruda, Merck) among a planned 220 patients with unresectable, locally advanced or metastatic mucosal melanoma. PFS serves as the study’s primary endpoint, with objective response rate, duration of response, OS and safety as secondary endpoints.
A phase 1b study evaluating toripalimab plus axitinib, a VEGFR inhibitor, showed an ORR of 48.3%, a disease control rate of 86.2% and median PFS of 7.5 months among patients with advanced mucosal melanoma. The trial also showed a manageable safety profile.
The FDA previously granted this application orphan drug designation.
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