Article
FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non-Small Cell Lung Cancers Harboring BRAF V600E Mutations.
The oncologist - 1 Jun 2018
Odogwu Lauretta, Mathieu Luckson, Blumenthal Gideon, Larkins Erin, Goldberg Kirsten B, Griffin Norma, Bijwaard Karen, Lee Eunice Y, Philip Reena, Jiang Xiaoping, Rodriguez Lisa, McKee Amy E, Keegan Patricia, Pazdur Richard
Abstract excerpt
On June 22, 2017, the Food and Drug Administration expanded indications for dabrafenib and trametinib to include treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring BRAF V600E mutations. Approval was based on results from an international, multicenter, multicohort, noncomparative, open-label trial, study BRF113928, which sequentially enrolled 93 patients who had received previous...
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