The U.S. Food and Drug Administration (FDA) announced that it has accepted Bristol Myers Squibb’s supplemental biologics license application for the postsurgical use of the PD-1 inhibitor nivolumab in the treatment of patients with stage IIB or stage IIC melanoma, according to a report from Formulary Watch. The FDA’s decision comes after researchers have demonstrated that, compared with placebo, nivolumab successfully improved recurrence-free survival (89% vs 79%) in patients with stage IIB or stage IIC melanoma enrolled in the phase III CheckMate -76K trial. Nivolumab has already been approved for use in patients aged 12 years or older with metastatic or lymph node–involved melanoma, as well as those with non–small cell lung cancer, bladder cancer, and esophageal/gastroesophageal junction cancer. The FDA stated that it has set a Prescription Drug User Fee Act date of October 13, 2023.
May 24, 2023