China’s NMPA Approves Toripalimab in First-Line Melanoma
Source: OncLive, April 2025
China’s NMPA has approved the sNDA for toripalimab as a first-line treatment for patients with unresectable or metastatic melanoma.
China’s National Medical Products Administration has approved toripalimab (Tuoyi) for the frontline treatment of patients with unresectable or metastatic melanoma.
The approval was supported by data from the phase 3 MELATORCH study (NCT03430297). Data from MELATORCH showed that patients who received the anti-PD–1 monoclonal antibody (n = 127) achieved a median progression-free survival (PFS) of 2.3 months compared with 2.1 months among patients treated with dacarbazine (n = 128; HR, 0.708; 95% CI, 0.526-0.954; P = .0209). Moreover, the median overall survival (OS) was 15.1 months vs 9.4 months, respectively (HR, 0.680; 95% CI, 0.486-0.951). The safety profile of toripalimab was consistent with previous studies, and no new safety signals were reported.