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BMS’ Opdivo (nivolumab) Receives EC’s Approval as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer

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BMS’ Opdivo (nivolumab) Receives EC’s Approval as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer

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  • The EC has approved Opdivo + Pt-based CT for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%
  • The approval was based on the P-III trial (CheckMate -816) evaluating Opdivo + CT vs CT alone which showed a clinical improvement in EFS and pCR & the safety profile was consistent with prior reported studies. In all-randomized patients at follow-up of 21mos., m-PFS (31.6 vs 20.8mos.), 24% vs 2.2% achieved pCR, OS showed a 43% reduction in risk of death
  • Opdivo + CT was approved for neoadjuvant treatment of patients with resectable NSCLC in 21 countries, incl. the US, Japan & China, and additional regulatory applications are under review by global health authorities

Ref: BMS Image: BMS

Related News:- BMS Reports Sub-Study Results of the P-III Trial (CheckMate -901) for Opdivo (nivolumab) to Treat Unresectable or Metastatic Urothelial Carcinoma

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Senior Editor

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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