nivolumab2015年说明书.pdf

Targeting the gatekeeper: Osimertinib in EGFR T790M mutation-positive non-small cell lung cancer. Ferdinandos Skoulidis and Vassiliki A. Papadimitrakopoulou Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center Corresponding Author:Vassiliki A. Papadimitrakopoulou, The University of Texas MD Anderson Cancer Center, Houston, TX 77030 Phone: 713-7926363 Fax: 713-792-1220 Email:vpapadim@ Running title: Osimertinib in EGFR T790M mutation-positive NSCLC Disclosure of Potential Conflicts of Interest: V. A. Papadimitrakopoulou reports receiving commercial research grants from AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Clovis Oncology, Genentech, Janssen, Merck, Novartis, and Pfizer, and is a consultant/advisory board member for ARAD, AstraZeneca, Genentech, Janssen, and Merck. No potential conflicts of interest were disclosed by the other author. 1 Abstract In 2015 the FDA approved an unprecedented number of new therapies for non-small cell lung cancer (NSCLC), among them therapies addressing specific genomic tumor subsets in the setting of development of resistance to front-line targeted therapy. Osimertinib (TagrissoTM, AZD9291) is indicated for patients with metastatic EGFR (epidermal growth factor receptor) T790M mutation-positive NSCLC, as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy and received breakthrough therapy designation, priority review status, and accelerated approval. Introduction The treatment of NSCLC bearing activating mutations in EGFR with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) represents a paradigm of science-driven personalized cancer the