FDA Grants Regular Approval to Tagrisso For Certain Patients with NSCLC

The FDA has approved osimertinib for the treatment of metastatic non small cell lung cancer, reports Healio.

The approval allows osimertinib (Tagrisso, AstraZeneca) to be used for patients whose tumors harbor epidermal growth factor receptor T790Mmutations detected by an FDA–test, and whose disease progressed on or after EGFR tyrosine kinase inhibitor therapy.

The FDA had granted accelerated approval to osimertinib for this indication in November 2015 based on results of two single-arm clinical trials, which showed the agent induced an overall response rate of 59%.

The agency based the regular approval on results of the randomized AURA3 trial, which included 419 patients with metastatic EGFR T790Mmutation–positive NSCLC as identified by the cobas EGFR mutation test (Roche Molecular Systems). All patients had progressed after first-line therapy with an EGFR tyrosine kinase inhibitor.

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