Henlius Reports EMA’s Validation of MAA for Hansizhuang (serplulimab) as 1L Treatment of Extensive-Stage Small Cell Lung Cancer
Shots:
- The EMA has validated the application for Hansizhuang (serplulimab) in combination with CT (carboplatin and etoposide) for adults with ES-SCLC
- The application was based on the results from the P-III study (ASTRUM-005) evaluating the efficacy and adverse event profile of serplulimab + CT vs PBO + CT in 585 patients at 128 sites in multiple countries incl. China, Poland, Turkey, and Georgia. The results were presented at ASCO 2022 & were then published in the JAMA
- Hansizhuang, an anti-PD-1 mAb received ODD from the US FDA & EC for the treatment of SCLC. The therapy was also approved in China for the treatment of MSI-H solid tumors, sq. NSCLC and ES-SCLC
Ref: PRNewswire | Image: Henlius
Related News:- Henlius' Hansizhuang (serplulimab) Receives the NMPA’s Approval as 1L Treatment of Extensive Stage Small Cell Lung Cancer
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