BMS’s Opdivo (nivolumab) Receives the US FDA’s Approval as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer
Shots:
- The approval was based on the P-III (CheckMate -816) trial to evaluate Opdivo (360mg) + Pt doublet CT vs CT alone in 358 adult patients with resectable NSCLC regardless of PD-L1 expression
- The results showed an improvement in EFS with a 37% reduction in the risk of progression, recurrence, or death, m-EFS (31.6mos. vs 20.8mos.), 24% vs 2.2% of patients achieved pCR. The results will be presented at AACR Annual Meeting 2022
- The application was approved under the US FDA’s RTOR pilot program to provide safe & effective treatments to patients while the review was also conducted under the FDA’s Project Orbis initiative by the health authorities in Australia, Canada & UK
Ref: BMS | 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.
