BMS Receives EMA’s CHMP Positive Opinion Recommending Approval of Opdivo (nivolumab) for Completely Resected Stage IIB or IIC Melanoma
Shots:
- The EMA’s CHMP adopted the positive opinion recommending approval of Opdivo as monotx. for adults & adolescents aged ≥12yrs. with completely resected stage IIB or IIC melanoma
- The recommendation was based on the P-III trial (CheckMate -76K) evaluating Opdivo (480mg, q4w for ~12mos.) vs PBO which showed a reduction in risk of recurrence or death by 58% with a minimum follow-up of 7.8mos., significant & clinical benefit in recurrence-free survival & the safety profile was consistent with prior reported studies
- The results from CheckMate -76K study were presented at SMR 2022. Opdivo was also approved in the EC for adjuvant treatment of melanoma with involvement of lymph nodes or metastatic disease that have undergone complete resection
Ref: Businesswire | Image: BMS
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
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.
