BMS’ Opdivo (nivolumab) Receives EC’s Approval as an Adjuvant Treatment for Completely Resected Stage IIB or IIC Melanoma
- 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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at firstname.lastname@example.org
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 email@example.com.