EC Grants AstraZeneca’s Lung Cancer Conditional Marketing OK
The European Commission (EC) has granted conditional marketing authorization for AstraZeneca’s Tagrisso (osimertinib) 80-mg once-daily tablets for treating adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
The European Union marketing authorization was received through the accelerated assessment procedure of the European Medicines Agency (EMA). This approval follows US accelerated approval granted in November 2015 and availability in the UK under the Early Access to Medicines Scheme in December 2015. In Japan, osimertinib was granted priority review by the Pharmaceuticals and Medical Devices Agency. Interactions with regulatory authorities in the rest of the world are ongoing.
Osimertinib is indicated for patients with T790M mutation-positive NSCLC, irrespective of previous treatment with an EGFR tyrosine kinase inhibitor (TKI). Eligibility for treatment with osimertinib will be dependent on mutation status, to be determined through a validated diagnostic test based on a tumor tissue sample or plasma. Availability of a blood-based test for circulating tumour DNA (ctDNA) means that physicians and patients have multiple options to test for a T790M mutation, according to the company.