FDA Accepts Supplemental BLA For Nivolumab For Melanoma
Source: Drug Topics, March 2023
The FDA has accepted the supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) as adjuvant monotherapy for patients with completely resected stage IIB or IIC melanoma, according to a Bristol Myers Squibb press release.1 The PDUFA date for this sBLA is October 13, 2023.
The sBLA submission was based on safety and efficacy results of the pivotal CheckMate-76K clinical trial. Results from this phase 3, randomized, double-blind clinical trial were previously shared in October 2022 in both a company press release2 and as late-breaking data during a plenary session at the Society for Melanoma Research annual meeting.
Results of the CheckMate-76K trial showed a “statistically significant and clinically meaningful” benefit in recurrence-free survival vs placebo in this patient population. At the time of the pre-specified interim analysis, CheckMate-76K met the primary endpoint (recurrence-free survival) and reduced the risk of recurrence or death by 58% vs placebo (hazard ratio [HR], 0.42; 95% CI, 0.30-0.59). Twelve-month recurrence-free survival rates were also higher vs placebo (89% vs 79%; 95% CI, 86-92 and 74-84, respectively).