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Oncol Ther (2018) 6:45–58 https://doi.org/10.1007/s40487-018-0061-y ORIGINAL RESEARCH Osimertinib for Previously Treated Patients With Advanced EGFR T790M Mutation-Positive NSCLC: Tolerability and Diagnostic Methods From an Expanded Access Program . . . . Edgardo S. Santos Barry Kaplan Eli Kirshner Elisabeth F. Croft . . . Lecia V. Sequist MyDoanh Chau Jiefen Munley Geoffrey R. Oxnard Received: April 3, 2018 / Published online: May 25, 2018 The Author(s) 2018 and diagnostic methods used for T790M testing ABSTRACT in the EAP. Methods: Adult patients with EGFR T790M- Introduction: The osimertinib (AZD9291) US positive NSCLC following progression on prior Expanded Access Program (EAP) provided com- EGFR-TKI therapy (irrespective of line of ther- passionate access to osimertinib prior to US apy) were enrolled in the EAP and treated with Food and Drug Administration (FDA) approval 80 mg osimertinib once daily until dose reduc- for patients with advanced/metastatic epider- tion, discontinuation, or completion of the EAP mal growth factor receptor (EGFR) T790M-pos- following FDA approval (November 2015). Var- itive non-small cell lung cancer (NSCLC) ious testing methods were allowed for the following progression on tyrosine kinase inhi- required T790M testing. bitors (TKIs) targeting EGFR. Here, we report the Results: In total, 248 patients from 25
Oncology and Therapy – Springer Journals
Published: May 25, 2018
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