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