The China National Medical Products Administration (NMPA) has accepted for review Junshi Biosciences’ supplemental new drug application (sNDA) for toripalimab (TUOYI) to treat unresectable or metastatic melanoma. This sNDA is underpinned by the results of the MELATORCH study, a Phase III clinical trial demonstrating positive outcomes for toripalimab in comparison to dacarbazine. The gold standard of business intelligence.
The multicentre, randomised, open-label, positive-controlled study assessed the efficacy and safety of toripalimab plus dacarbazine as a first-line treatment for unresectable or metastatic melanoma in systemic treatment-naïve patients. It was carried out at 11 clinical centres across China. In September 2023, the trial met its primary endpoint of progression-free survival (PFS).
Patients treated with toripalimab experienced a significant prolongation of PFS compared to those receiving dacarbazine. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form The safety profile of toripalimab was consistent with previous studies, with no new safety concerns identified.
Toripalimab is an anti-PD-1 monoclonal antibody designed to hi.