UK NICE recommends Tagrisso (osimertinib) for use in advanced or metastatic EGFR T790M mutation-positive non-small-cell lung cancer- AstraZeneca

The UK National Institute for Health and Care Excellence (NICE) has conditionally recommended Tagrisso (osimertinib), from AstraZeneca, as an option for use within the newly reformed Cancer Drugs Fund for treating locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer in adults whose disease has progressed only after first-line treatment with an EGFR tyrosine kinase inhibitor. NICE had previously rejected Tagrisso in a preliminary recommendation. The reference to the Cancer Drugs Fund is subject to AstraZeneca providing a discount and the collection of long term data on the drug. The Cancer Drugs Fund is now a "managed access" fund for drugs that NICE recommends conditionally.

The key clinical-effectiveness evidence for osimertinib was taken from the non-randomised, non-controlled, single-arm AURA extension and AURA2 studies that included people with EGFR T790M mutation-positive NSCLC whose disease had progressed while having a TKI.

Comment: Targrisso has a conditional marketing authorisation 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 marketing authorisation is conditional upon the company submitting the clinical study report of the phase III AURA3 study comparing osimertinib with platinum-based doublet chemotherapy (expected June 2017).