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FDA Approves Adjuvant Nivolumab for Melanoma

Silas Inman @silasinman
Published: Wednesday, Dec 20, 2017

Jeffrey Weber, MD

Jeffrey Weber, MD
The FDA has approved nivolumab (Opdivo) as an adjuvant treatment for patients with completely resected melanoma with lymph node involvement or metastatic disease, based on findings from the phase III CheckMate-238 trial.

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), which was approved by the FDA as an adjuvant therapy for melanoma in 2015. 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. The FDA-approved recommended dose for adjuvant nivolumab is 240 mg every 2 weeks.

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