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