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Osimertinib Receives Full FDA Approval for T790M-Positive NSCLC

Posted: Monday, April 24, 2017

On March 30, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to osimertinib (Tagrisso) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation–positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy. In November 2015, osimertinib received accelerated approval for this indication based on an overall response rate of 59% among 411 patients in two single-arm clinical trials.

The current approval is based on the AURA3 trial (ClinicalTrials.gov identifier NCT012151981), a randomized, multicenter open-label, active-controlled trial conducted in patients with metastatic EGFR T790M mutation–positive NSCLC who had progressive disease following first-line EGFR tyrosine kinase therapy. All patients were required to have EGFR T790M mutation–positive NSCLC identified by the cobas EGFR mutation test performed in a central laboratory.

The recommended dose of osimertinib is 80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity. The presence of an EGFR T790M mutation in a tumor specimen or plasma specimen (if tumor tissue is unavailable) should be confirmed by an FDA-approved test prior to initiation of treatment.