FDA Accepts sNDA for Osimertinib in First-Line Treatment of EGFR-Mutated NSCLC

On December 18, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for the use of osimertinib (Tagrisso)—a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central nervous system (CNS) metastases—in the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations).

The FDA has granted osimertinib Priority Review status, and previously granted Breakthrough Therapy Designation in the first-line treatment of patients with metastatic EGFR mutation–positive NSCLC.

The submission acceptance is based on data from the phase III FLAURA trial, in which osimertinib significantly improved progression-free survival compared to current first-line EGFR tyrosine kinase inhibitors erlotinib (Tarceva) or gefitinib (Iressa) in previously untreated patients with locally advanced or metastatic EGFR mutation–positive NSCLC.

On September 28, 2017, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were updated to include the use of osimertinib in the first-line treatment of patients with metastatic EGFR mutation–positive NSCLC. The use of osimertinib in this indication is not yet approved by the FDA.

About the FLAURA trial

The FLAURA trial assessed the efficacy and safety of osimertinib 80 mg once daily vs standard-of-care EGFR tyrosine kinase inhibitors (either oral erlotinib 150 mg once daily or oral gefitinib 250 mg once daily) in previously untreated patients with locally advanced or metastatic EGFR-mutated NSCLC.

The trial was a double-blinded, randomized trial, with 556 patients across 29 countries.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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