AstraZeneca announced that the European Commission (EC) has granted conditional marketing authorization for Targrisso osimertinib tablets for the treatment of adult patients with a type of mutating non-small cell lung cancer.
Use can be indicated with a blood-based test..
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Osimertinib defines a new generation of targeted EGFR-TKI treatments, and the European Commission’s expedited approval reflects the importance of this innovative medicine for addressing the needs of patients with lung cancer who have the T790M mutation. We are now building on our understanding of the clinical activity of osimertinib to explore its full potential in patients with EGFRm lung cancer in multiple treatment settings.”
Dr Matthew Peters, chair of the Global Lung Cancer Coalition, added: “It is an exciting time in the care of patients with lung cancer. The ability to precisely characterisz patients who have different types of lung cancer based on genetic mutations, and predict their response to targeted treatments, offers a more accurate and efficient approach to lung cancer care. Patients with common sensitising EGFR mutations and the separate T790M have disappointing responses to standard treatments. Testing for the T790M status of lung cancer patients, using either a tumor sample or a simple blood test, and directing patients towards a medication such as osimertinib that is specifically designed for their pattern of mutations, offers greater prospects for durable treatment outcomes.”
The EU approval for osimertinib is based on data from two Phase II studies that indicate the drug’s median progression-free survival (PFS) was 9.7 months in the combined Phase II studies and 11 months in the Phase I trial.
This OK 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 (PMDA).
AstraZeneca has about 2,100 employees in Delaware.
