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Henlius Reports EMA’s Validation of MAA for Hansizhuang (serplulimab) as 1L Treatment of Extensive-Stage Small Cell Lung Cancer

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Henlius Reports EMA’s Validation of MAA for Hansizhuang (serplulimab) as 1L Treatment of Extensive-Stage Small Cell Lung Cancer

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  • 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

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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