BMS’ Opdivo (nivolumab) Receives the EC’s Approval as Adjuvant Treatment for Patients with High-Risk Muscle-Invasive Urothelial Carcinoma
Shots:
- The approval was based on the P-III (CheckMate -274) trial evaluating Opdivo (240mg, q2w for ~1yr.) vs PBO in a ratio (1:1) in 709 patients with MIBC
- The results showed an improvement in DFS in all-randomized patients & tumor cells express PD-L1 ≥1%, 47% reduction in risk of disease recurrence or death in patients with tumor cell PD-L1 expression ≥1%; m-DFS (not reached vs 8.41mos.), was well tolerated & the safety profile was consistent with Opdivo studies
- The approval allows the use of Opdivo in the 27 member states of the EU, Iceland, Liechtenstein & Norway. The company has a broad development program in earlier stages of cancer that spans 8 different tumors in multiple settings
Ref: Businesswire | Image: BMS
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