Categorized | Melanoma News, Regulatory

FDA Approves Opdivo For Resected Melanoma

Source: Healio, December 2017

The FDA approved nivolumab injection for the adjuvant treatment of patients with melanoma who have involved lymph nodes or metastatic disease and who underwent complete resection.
Nivolumab (Opdivo, Bristol-Myers Squibb) is the first anti-PD-1 immune checkpoint inhibitor indicated for the adjuvant treatment of melanoma. This approval includes patients with mutated and wild-type
The FDA based the approval on results from the phase 3 randomized double-blind CheckMate 238 trial, which enrolled 906 patients with complete resection of stage IIIB/C or stage IV melanoma.
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