BMS’ Opdivo (nivolumab) Receives the US FDA’s Approval as Adjuvant Treatment for Completely Resected Stage IIB or Stage IIC Melanoma
Shots:
- The US FDA has approved Opdivo for adjuvant treatment of adult & pediatric patients aged ≥12yrs. with completely resected stage IIB or IIC melanoma. The approval was based on the P-III trial (CheckMate -76K) evaluating Opdivo (480mg, IV, q4w) vs PBO
- The results showed a 58% reduction in risk of recurrence, new primary melanoma, or death, RFS rate (89% vs 79%) at 1yr. In a pre-specified exploratory subgroup analysis, the RFS unstratified HR in patients with stage IIB & IIC melanoma (0.34 & 0.51), 1 yr. RFS rates 93% vs 84% in stage IIB; 84% vs 72% in stage IIC
- The results will be presented at the SMR annual meeting. Opdivo was approved in the US for the adjuvant treatment of adult & pediatric patients aged ≥12yrs. with melanoma with involvement of lymph nodes or metastatic disease
Ref: BMS | Image: BMS
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