BMS Report EMA's Validation for Opdivo (nivolumab) as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer
Shots:
- The EMA has validated the type II variation application for Opdivo + CT which was based on P-III (CheckMate -816) trial evaluating Opdivo + CT vs CT alone in 358 patients with resectable stage IB to IIIA NSCLC
- The results showed a significant & clinical improvement in EFS & pCR & the safety profile was consistent with previously reported studies in NSCLC. The pCR results were presented at AACR 2021 & EFS results will be presented at AACR 2022
- With the validation, the submission is complete & the EMA will now initiate the review procedure. If approved, the Opdivo regimen will be the 1st immunotherapy-based option authorized for use before surgery in patients with NSCLC in the EU
Ref: Business wire | Image: BMS
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