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CStone Pharmaceuticals’ Cejemly Receives the CHMP’s Positive Opinion for Treating NSCLC

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CStone Pharmaceuticals’ Cejemly Receives the CHMP’s Positive Opinion for Treating NSCLC

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  • The CHMP has granted positive opinion to Cejemly (sugemalimab) + CT as a 1L treatment of metastatic NSCLC
  • The positive opinion was supported by the P-III (GEMSTONE-302) study, demonstrating improvement in PFS & OS with sugemalimab + CT vs PBO + CT among treatment-naïve stage IV NSCLC patients. Results were published in The Lancet Oncology & Nature Cancer as well as highlighted international academic conferences
  • The marketing application of the combination is under review with MHRA for the same indication and is under discussions with the EMA, MHRA & US FDA for other indications. Additionally, it is seeking collaborations for sugemalimab apart from a deal Ewopharma in Central Eastern Europe and Switzerland

Ref: CStone | Image: CStone 

Related News:- CStone Reports P-III Study (GEMSTONE-304) Results of Sugelimab as 1L Treatment of Esophageal Squamous Cell Carcinoma

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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