Henlius Reports the NMPA Acceptance of NDA for Hansizhuang (serplulimab) to Treat Esophageal Squamous Cell Carcinoma
Shots:
- The NMPA has accepted the NDA for a new indication of Hansizhuang as 1L treatment of PD-L1+ unresectable LA/recurrent or metastatic ESCC. The approval was based on the P-III trial (ASTRUM-007) evaluating serplulimab vs PBO + CT (5-FU + cisplatin) in patients with previously untreated PD-L1+ (PD-L1 CPS≥1) advanced ESCC
- The results showed an improvement in PFS & OS. The PD-L1 high-expression group achieved survival benefits over the ITT group in the analysis of the group with PD-L1 CPS≥10, m-OS (18.6mos.) with an absolute extension of 4.7mos.
- 41% reduction in risk of death & the results were published in the international leading journal Nature Medicine. The company plans to submit an MAA for Hansizhuang as a 1L treatment for nsNSCLC in China in H2’23
Ref: PRNewswire | Image: Henlius
Related News:- Henlius Reports EMA’s Validation of MAA for Hansizhuang (serplulimab) as 1L Treatment of Extensive-Stage Small Cell Lung Cancer
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