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Adjuvant Nivolumab Approved in Europe for Melanoma

Jason M. Broderick @jasoncology
Published: Tuesday, Jul 31, 2018

James Larkin, MD, PhD

James Larkin, MD, PhD

The European Commission has approved nivolumab (Opdivo) as an adjuvant treatment for adult patients with completely resected melanoma with lymph node involvement or metastatic disease, regardless of BRAF mutation status.

“This is an important new treatment option, as the data support the benefit of nivolumab across a broad range of patients to address concerns around recurrence postsurgery,” added Larkin.

In the CheckMate-238 trial, patients with stage IIIB/C or IV melanoma were randomized to 1 year of treatment with nivolumab (n = 453) or ipilimumab (n = 453). Nivolumab was administered at 3 mg/kg every 2 weeks and ipilimumab was given at 10 mg/kg every 3 weeks for 4 doses then every 12 weeks.
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