BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC
Shots:
- The CHMP has recommended Opdivo + Pt-based CT as neoadj. followed by Opdivo alone as adj. treatment of adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1%. If approved, EC’s decision would be valid in all 30 EEA states
- The P-III (CheckMate-77T) study assessed neoadj. Opdivo + CT, followed by surgery & adj. Opdivo alone vs CT & PBO in 461 pts with resectable stage IIA to IIIB NSCLC
- Trial showed improved EFS (1EP), along with improvements in 2EPs of pCR & major pathologic response (MPR), while OS remains under assessment; data was presented at ESMO congress 2023 & published in The NEJM
Ref: BMS | Image: BMS
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