Article
FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation.
The oncologist - 1 Mar 2018
Odogwu Lauretta, Mathieu Luckson, Goldberg Kirsten B, Blumenthal Gideon M, Larkins Erin, Fiero Mallorie H, Rodriguez Lisa, Bijwaard Karen, Lee Eunice Y, Philip Reena, Fan Ingrid, Donoghue Martha, Keegan Patricia, McKee Amy, Pazdur Richard
Abstract excerpt
On March 30, 2017, the U.S. Food and Drug Administration (FDA) approved osimertinib for the treatment of patients with metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive, non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed following EGFR tyrosine kinase inhibitor (TKI) therapy. Approval was based on demonstration of a statistically...
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