Junshi Bio's PD-1 single anti-Trump treatment of urinary skin cancer, supplementary new drug application accepted by NMPA
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Last Update: 2020-05-29
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Source: Internet
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Author: User
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Junshi Biosannounc signed that the National Drug Administration (NMPA) has accepted its PD-1 single anti-triprib supplementary new drug application (sNDA) for second-line treatment for patients with advanced local or metastatic urinary disease who have received systemic treatmenturinary tract cancer is the most common bladder cancer in China (more than 90%)The number of new cases of bladder cancer in the country is about 80,000 a year, ranking ninth among all cancer deaths and accounting for about 14% of all bladder cancer deaths worldwidethe results of a phase II clinical trial based on the POLARIS-03 study (NCT03113266), in which 151 patients participatedThe study assessed the efficacy and safety of toripalimab in patients with advanced local or metastatic urinary tract cancer who failed to treat the standard systempreliminary results presented at the ASCO-GU 2020 conference on 6 January 2020 showed that the objective remission rate (ORR) of 148 assessable patients was 25.7% and the ORR in 46 PD-L1 plus patients was 41.3%In China, patients with advanced urinary skin cancer who failed standard chemotherapy have limited treatment optionsIf approved, toripalimab can provide an alternative therapy regardless of pD-L1 expression status
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