Article
U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab.
Clinical cancer research : an official journal of the American Association for Cancer Research - 15 Jul 2017
Hazarika Maitreyee, Chuk Meredith K, Theoret Marc R, Mushti Sirisha, He Kun, Weis Shawna L, Putman Alexander H, Helms Whitney S, Cao Xianhua, Li Hongshan, Zhao Hong, Zhao Liang, Welch Joel, Graham Laurie, Libeg Meredith, Sridhara Rajeshwari, Keegan Patricia, Pazdur Richard
Abstract excerpt
On December 22, 2014, the FDA granted accelerated approval to nivolumab (OPDIVO; Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Approval was based on a clinically meaningful, durable objective response rate (ORR) in a non-comparative analysis of 120 patients who...
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