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Osimertinib Receives Breakthrough Therapy Designation for NSCLC in First-Line

Jason Harris
Published: Monday, Oct 09, 2017

Sean Bohen, MD, PhD
Sean Bohen, MD, PhD
The FDA has awarded Breakthrough Therapy Designation to osimertinib (Tagrisso) for first-line treatment of patients with metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC).

mutation-positive NSCLC is not yet FDA approved.
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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