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
Click here to read the full press release
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.