The European Commission (EC) has granted full marketing authorisation for osimertinib 40mg and 80mg once-daily tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

The approval is based on the results of the Phase III AURA3 trial, which were presented last year and published recently in The New England Journal of Medicine .

This follows a preliminary decision by NICE in June to not recommend osimertinib in the UK based on cost, followed by an updated approval given funding allocated through the Cancer Drugs Fund in November.

Meanwhile in the US, osimertinib received FDA approval in March for relapsed EGFR NSCLC.

Data from the Phase III AURA3 trial showed that osimertinib demonstrated statistically-significant improvements in progression-free survival (PFS) over standard platinum-based doublet chemotherapy in 419 patients with EGFR T790M-positive advanced NSCLC whose disease had progressed on or after EGFR tyrosine kinase inhibitor therapy.

Among patients taking osimertinib, the PFS was 10.1 months, compared to 4.4 months in the chemotherapy arm.

The objective response rate (ORR) was 71% compared to 31% for chemotherapy.

Among 144 patients with metastases to the central nervous system (CNS), PFS was 8.5 months versus 4.2 months.

The most common adverse reactions in the osimertinib group were diarrhoea (41% overall; 1% Grade ≥3), rash (34% overall; 1% Grade ≥3), dry skin (23% overall; 0% Grade ≥3), paronychia (22% overall; 0% Grade ≥3), stomatitis (15% overall; 0% Grade ≥3, and pruritus (13% overall; 0% Grade ≥3).

Warnings and precautions include interstitial lung disease (ILD), keratitis, left ventricular ejection fraction (LVEF) and QTc interval prolongation.

Source: PharmaTimes