Article
FDA Approval of Gefitinib for the Treatment of Patients with Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer.
Clinical cancer research : an official journal of the American Association for Cancer Research - 15 Mar 2016
Kazandjian Dickran, Blumenthal Gideon M, Yuan Weishi, He Kun, Keegan Patricia, Pazdur Richard
Abstract excerpt
On July 13, 2015, the FDA approved gefitinib (Iressa; AstraZeneca UK Limited) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Concurrently, a labeling expansion of the therascreen EGFR RGQ PCR Kit (Qiagen) as a companion diagnostic test was approved. The approval...
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