CStone Pharmaceuticals’ Cejemly Receives the CHMP’s Positive Opinion for Treating NSCLC
Shots:
- 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 Pharma| Image:CStone Pharma| Press Release
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