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FDA Accepts New Drug Application for First-Line Osimertinib in EGFR-Mutated NSCLC

By: Sarah Jackson
Posted: Tuesday, December 19, 2017

On December 18, 2017, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application for the use of osimertinib (Tagrisso) in the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations.

Osimertinib, a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) has shown clinical activity against central nervous system metastases. The submission acceptance is based on data from the phase III FLAURA trial, in which osimertinib significantly improved progression-free survival compared with current first-line EGFR TKIs (erlotinib or gefitinib) in previously untreated patients with locally advanced or metastatic EGFR-mutant NSCLC.

In September 2017, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) were updated to include the use of osimertinib in the first-line treatment of patients with metastatic EGFR-mutant NSCLC. The use of osimertinib in this indication has not yet been approved by the FDA.