Jedd D. Wolchok, MD, PhD
The FDA has granted an accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) as a treatment for patients with BRAF V600
wild-type unresectable or metastatic melanoma, based on findings from the phase II CheckMate-069 study.
The most frequently observed AEs with the combination versus the single-agent were colitis (17% vs 9%), diarrhea (9% vs 7%), pyrexia (6% vs 7%), and pneumonitis (5% vs 0). The most common AEs with the combination versus the single-agent, respectively, were rash (67% vs 57%), pruritus (37% vs 26%), headache (24% vs 20%), vomiting (23% vs 15%), and colitis (22% vs 11%).
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