Medication Monitor

Generic Name (Trade Name—Company)
May 8, 2018


Osimertinib approved as first-line treatment for EGFR-mutated non–small cell lung cancer

AstraZeneca announced FDA approval of osimertinib for first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions, or exon 21 L858R mutations), as detected by an FDA-approved test.

Approval was based on results from the Phase III FLAURA trial, which compared osimertinib to current first-line EGFR tyrosine kinase inhibitors, erlotinib or gefitinib, in previously untreated patients with locally advanced or metastatic EGFR-mutated (EGFRm) NSCLC. The agent met the primary endpoint of progression-free survival.

The agent was previously approved for second-line treatment of patients with metastatic EGFRm NSCLC whose disease has progressed on or after a first-line EGFR-TKI therapy and who have developed the secondary T790M mutation, as detected by an FDA-approved test.