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BMS Receives EMA’s CHMP Positive Opinion Recommending Approval of Opdivo (nivolumab) as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer

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BMS Receives EMA’s CHMP Positive Opinion Recommending Approval of Opdivo (nivolumab) as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer

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  • The EMA’s CHMP adopted the positive opinion recommending the approval of Opdivo + Pt-based CT for resectable NSCLC who are at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%
  • The opinion was based on the P-III trial (CheckMate -816) evaluating Opdivo (360mg, q3w) + CT vs CT alone which showed an improvement in EFS & pCR with 3 cycles of Opdivo + CT vs CT alone
  • The safety profile was consistent with prior reported studies while the 3yr. data showed a durable clinical benefit. The combination therapy was approved for resectable NSCLC regardless of PD-L1 expression levels in 21 countries, incl. the US, Japan & China, additional regulatory applications are under review by global health authorities

Ref: BMS | Image: BMS

Related News:- BMS to Present P-III Study (COMMANDS) of Reblozyl (luspatercept-aamt) as 1L Treatment of Anemia in Adults with Lower-Risk MDS at ASCO and EHA 2023

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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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