FDA approves Tagrisso for first line treatment of NSCLC with epidermal growth factor receptor (EGFR) mutations.- AstraZeneca.

AstraZeneca announced that the FDA has approved Tagrisso (osimertinib) 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), as detected by an FDA-approved test. The approval is based on results from the Phase III FLAURA trial, which were presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine.

See-"Osimertinib in Untreated EGFR-Mutated Advanced Non�Small-Cell Lung Cancer"-Jean-Charles Soria, M.D., Ph.D., Yuichiro Ohe, M.D., Ph.D., Johan Vansteenkiste, M.D., Ph.D., et al., for the FLAURA Investigators-January 11, 2018 N Engl J Med 2018; 378:113-125 DOI: 10.1056/NEJMoa1713137.

Comment:In the US, Tagrisso is already approved for the 2nd-line treatment of patients with metastatic EGFRm NSCLC, whose disease has progressed on or after a 1st-line EGFR-TKI therapy and who have developed the secondary T790M mutation, as detected by an FDA-approved test.