Osimertinib for 1st-line NSCLC treatmentJune 29, 2018
Tagrisso (osimertinib) has been granted approval by US FDA for the 1st-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).
The approval is based on results from the phase 3 FLAURA trial, which were presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine.
The FLAURA trial compared osimertinib to current 1st-line EGFR tyrosine kinase inhibitors (TKIs)— erlotinib or gefitinib — in previously-untreated patients with locally-advanced or metastatic EGFR-mutated (EGFRm) NSCLC. Osimertinib met the primary endpoint of progression-free survival (PFS). PFS results with osimertinib were consistent across all pre-specified patient subgroups, including patients with or without central nervous system (CNS) metastases. Overall survival data were not mature at the time of the final PFS analysis.
Osimertinib is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases.