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FDA Grants Frontline Osimertinib Priority Review for NSCLC

Jason M. Broderick @jasoncology
Published: Monday, Dec 18, 2017

The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of osimertinib (Tagrisso) as a first-line treatment for patients with non–small cell lung cancer (NSCLC) whose tumors harbor EGFR mutations (exon 19 deletions or exon 21 [L858R] substitution mutations).

 mutation–positive NSCLC.
Ramalingam S, Reungwetwattana T, Chewaskulyong B, et al. Osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with EGFRm advanced NSCLC: FLAURA. Presented at: 2017 ESMO Congress; Madrid, Spain; September 9-12, 2017. Abstract LBA2_PR.

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Online CME Activities
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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