Toripalimab sNDA Under Review in China for Frontline Unresectable or Metastatic Melanoma
Source: OncLive, August 2024
A sNDA seeking the approval of toripalimab for frontline use in patients with unresectable or metastatic melanoma is under review by the NMPA.
The National Medical Products Administration has accepted for review a supplemental new drug application (sNDA) seeking the approval of toripalimab (Tuoyi) for use in the first-line treatment of patients with unresectable or metastatic melanoma.
The sNDA is supported by findings from the phase 3 MELATORCH study (NCT03430297), which met its primary end point when toripalimab significantly improved progression-free survival (PFS) over dacarbazine in this population.2 The toxicity profile of the PD-1 antibody proved to align with what has previously been reported, with no new safety signals observed.