BMS’ Opdivo (nivolumab) Receives EC’s Approval as an Adjuvant Treatment for Completely Resected Stage IIB or IIC Melanoma
Shots:
- The EC has approved Opdivo as monotx. for the adjuvant treatment of adults & adolescents aged ≥12yrs. with stage IIB or IIC melanoma who have undergone complete resection
- The approval was based on the results from the P-III trial (CheckMate -76K) evaluating Opdivo (480mg, q4w for ~12mos.) vs PBO which showed a 58% reduction in risk of recurrence or death with a minimum follow-up of 7.8mos., 12mos. RFS rates were 89% vs 79%, RFS benefit was observed across predefined subgroups incl. T category and disease stage
- The safety profile was consistent with prior reported studies. Opdivo (PD-1 immune checkpoint inhibitor) is currently approved in 65+ countries, incl. the US, the EU, Japan, and China
Ref: Businesswire | Image: BMS
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