FDA-Approved

Osimertinib Now Fully Approved for T790M-Positve NSCLC

On 27 March 2017, the third-generation epidermal growth factor receptor (EGFR) targeting tyrosine kinase inhibitor (TKI) osimertinib (Tagrisso®, AstraZeneca) was granted a full approval by the FDA for patients with metastatic non-small cell lung cancer (NSCLC) that express the EGFR T790M mutation and have progressed on first-line treatment with an EGFR inhibitor.

Osimertinib was granted an accelerated approval for this indication in November 2015 on the basis of ORR in two single-arm clinical trials. The full approval is based on a significant improvement in PFS compared to pemetrexed-based chemotherapy (10.1 months vs 4.4 months; HR 0.3, P<.001) in the confirmatory phase III AURA3 trial.

primelines-approved