FDA Accepts Supplemental New Drug Application for Osimertinib as First-line Treatment in EGFR-mutant NSCLC

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Data from FLAURA may position osimertinib as the first-line standard of care for patients with EGFR-mutant NSCLC.
Data from FLAURA may position osimertinib as the first-line standard of care for patients with EGFR-mutant NSCLC.

The US Food and Drug Administration (FDA) accepted a supplemental New Drug Application for osimertinib as a first-line treatment for patients with EGFR-mutated metastatic non–small cell lung cancer (NSCLC), according to a press release.1

The FDA's acceptance was based on data from the phase 3 FLAURA trial (ClinicalTrials.gov Identifier: NCT02296125), which showed a median progression-free survival (PFS) of 18.9 months among patients with EGFR-mutant disease — an improvement of over 8 months vs the current standard of care.

Osimertinib, a third-generation tyrosine kinase inhibitor (TKI) of EGFR, has shown improved efficacy over erlotinib and gefitinib — both EGFR TKIs — and activity against central nervous system (CNS) metastases. Patients who develop resistance to erlotinib and gefitinib may also still respond to osimertinib. Data from FLAURA may position osimertinib as the standard of care for patients with ­EGFR­-mutant NSCLC.

EGFR mutations are found in 10% to 15% of patients in the US and Europe and in 30% to 40% of patients in Asia.

Osimertinib was granted Priority Review by the FDA. The drug was also previously granted Breakthrough Therapy Designation.


  1. US FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer [news release]. AstraZeneca; December 18, 2017. https://www.astrazeneca.com/media-centre/press-releases/2017/us-fda-accepts-regulatory-submission-for-tagrisso-in-1st-line-egfr-mutated-non-small-cell-lung-cancer-18122017.html. Accessed December 18, 2017.

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