Corporate Member AstraZeneca - NEW Indication

Corporate Member AstraZeneca - NEW Indication

TAGRISSO (Osimertinib)
June, 2017

The US Food and Drug Administration (FDA) granted full approval for TAGRISSO® (osimertinib) 80mg once-daily tablets, 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 an EGFR tyrosine kinase inhibitor (TKI) therapy. The full approval is based the randomized, Phase III AURA3 trial, where TAGRISSO significantly improved progression-free survival (PFS) versus platinum-based doublet chemotherapy, providing 10.1 months of median progression-free survival compared to 4.4 months from chemotherapy (hazard ratio 0.30; 70% risk reduction; 95% Confidence Interval [CI]: 0.23; 0.41; P<0.001). Additionally, TAGRISSO demonstrated efficacy in patients with measurable central nervous system (CNS) lesions at baseline. TAGRISSO was granted Fast Track, Breakthrough Therapy and Priority Review by the FDA, and received Accelerated Approval for this indication in 2015, based on tumor response rate and duration of response.

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