Tagrisso Gains Regular FDA Approval for NSCLC

The Food and Drug Administration (FDA) has approved Tagrisso (osimertinib; AstraZeneca) 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 (TKI) therapy.

Tagrisso was granted accelerated approval for this indication in November 2015 based on overall response rate (ORR) data of 59% among 411 patients from two single-arm trials.

The regular approval is supported by data from AURA3, a randomized, multicenter, open-label, active-controlled trial (n=413) conducted in patients with metastatic EGFR T790M mutation-positive NSCLC whose disease progressed after first-line EGFR TKI therapy. In AURA3, patients were randomized to either Tagrisso 80mg once daily or platinum-based doublet chemotherapy. The chemotherapy patients received either pemetrexed 500mg/m2 with carboplatin AUC5 or pemetrexed 500mg/m2 with cisplatin 75mg/m2 on Day 1 of every 21-day cycle for up to 6 cycles followed by pemetrexed as maintenance.

The study found an improvement in investigator-assessed progression-free survival (PFS), with a hazard ratio (HR) or 0.30 (95% CI: 0.23, 0.41; P<0.001). The estimated median PFS was 10.1 months in the Tagrisso arm vs. 4.4 months in the chemotherapy arm. Investigator-assessed confirmed ORR was 65% in the Tagrisso arm vs. 29% in the chemotherapy arm (P<0.0001). The estimated median response durations were 11 months in the Tagrisso arm vs. 4.2 months in the chemotherapy arms.

For patients with measurable central nervous system (CNS) lesions on baseline brain scans, the confirmed CNS ORR was 57% in the Tagrisso arm vs. 25% in the chemotherapy arm. The media CNS response duration was not yet reached in the Tagrisso arm (range 1.4-12.5 months) and was 5.7 months (range 1.4-5.7 months) in the chemotherapy arm.

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