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Osimertinib Approved in China for EGFR T790M+ NSCLC

Jason M. Broderick @jasoncology
Published: Monday, Mar 27, 2017

Sean Bohen, MD, PhD

Sean Bohen, MD, PhD

The China Food and Drug Administration (CFDA) has approved osimertinib for the treatment of patients with locally-advanced or metastatic EGFR T790M-positive non–small cell lung cancer (NSCLC) with progression following treatment with an EGFR tyrosine kinase inhibitor (TKI).

In the AURA trial, 201 patients at a median age of 62 years received osimertinib. Of patients enrolled, 30% were receiving osimertinib as second-line therapy while 70% were treated in the third-line setting. Ninety-eight percent of tumors tested positive for T790M.

In updated data from WCLC,2 the ORR was 61% (95% CI, 54-68). The median duration of response was not reached at the time of the analysis and the median PFS was also not yet calculable. At this analysis, only a quarter of events had occurred.

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TitleExpiration DateCME Credits
Advances in™ Therapies for Patients With ALK-Positive Lung Cancers: More Options…More Decisions…Better OutcomesAug 30, 20191.5
Oncology Briefings™: Treating Advanced NSCLC Without Actionable MutationsAug 30, 20191.0
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