FDA Upgrades Nivolumab to Regular Approval for Adjuvant Treatment of Advanced Melanoma

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The FDA upgrade was based on the CHECKMATE-238 study, a randomized, double-blind trial.
The FDA upgrade was based on the CHECKMATE-238 study, a randomized, double-blind trial.

The Food and Drug Administration (FDA) has approved Opdivo (nivolumab; Bristol-Myers Squibb) for the adjuvant treatment of patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection. 

The approval was based on the CHECKMATE-238 study, a randomized, double-blind trial involving 906 patients with completely resected, Stage IIIB/C or Stage IV melanoma. Patients were randomized to receive nivolumab 3mg/kg every 2 weeks (n=453) or ipilimumab (Yervoy; BMS) 10mg/kg every 3 weeks for 4 doses then every 12 weeks beginning at Week 24 for up to 1 year (n=453). The primary efficacy outcome measure was recurrence-free survival (RFS) defined as the time between the date of randomization and the date of first recurrence, new primary melanoma, or death, from any cause, whichever occurred first and as assessed by the investigator.

The results showed a statistically significant improvement in RFS for patients in the nivolumab-treated group compared with the ipilimumab arm (% of patients experiencing recurrence or death: 34% versus 45.5%, respectively; hazard ratio 0.65; 95% CI 0.53–0.8; P<0.0001); the median RFS was not reached on either arm.

Opdivo, a programmed death receptor-1 (PD-1) blocking antibody, is already indicated to treat various renal, urothelial, head and neck carcinomas; hepatocellular carcinoma, microsatellite instability-high or mismatch repair deficient colorectal cancer, classical Hodgkin lymphoma, melanoma, and non-small cell lung cancer.

For more information visit BMS.com.

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