Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced an expansion of indications for its immunotherapy drug Loqtorzi (toripalimab) following approval from China’s National Medical Products Administration (NMPA). The programmed death-1 (PD-1) inhibitor is now approved for use in combination with chemotherapy for the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC).
This latest green light comes on the heels of the EXTENTORCH study, a Phase III clinical trial that demonstrated the efficacy and safety of toripalimab in combination with chemotherapy compared to chemotherapy alone. The double-blind, placebo-controlled, multi-center study showed that the combination therapy significantly improved progression-free survival (PFS) and overall survival (OS) in patients with ES-SCLC, meeting the primary endpoint of the study.
Toripalimab, the first domestically developed PD-1 inhibitor in China to receive approval in December 2018 for the treatment of melanoma, has now garnered its ninth indication approval in the country. The drug has six indications that are included in China’s National Reimbursement Drug List (NRDL), marking a significant milestone for the company and patients in need.- Flcube.com
