Osimertinib receives approval for treatment of metastatic NSCLC

April 2018

The Food and Drug Administration (FDA) has approved the use of osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for first-line treatment of patients with metastatic Non-Small Cell Lung Cancer (mNSCLC) whose tumors have been tested and found to have specific genetic mutations as determined by an FDA-approved test. The tumor mutations that indicate treatment with osimertinib are in the Epidermal Growth Factor Receptor (EGFR) gene, and include mutations called “exon 19 deletions” or “exon 21 L858R” mutations.  The FDA approval was based on an international, multi-institution randomized clinical trial (designated FLAURA, NCT02296125) that involved 556 patients with metastatic NSCLC who had been tested and found to have exon 19 deletions or exon 21 L858R mutations. The results of this clinical trial demonstrated a Progression-Free Survival (PFS) of 17.6 months on average for patients being treated with osimertinib, as opposed to 9.6 months on average for patients not treated with omisertinab, but receiving standard of care treatment for this disease.