The European Commission (EC) has granted conditional marketing authorisation for AstraZeneca’s Tagrisso (AZD9291, osimertinib) 80mg once-daily tablets to treat adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive, non-small cell lung cancer (NSCLC).
Currently, osimertinib is approved to treat patients with T790M mutation-positive NSCLC, irrespective of previous treatment with an EGFR tyrosine kinase inhibitor (TKI).
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It is reported that eligibility for osimertinib treatment will depend on mutation status, which will be determined through a validated diagnostic test based on a tumour tissue sample or plasma.
According to the company, 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.
AstraZeneca global medicines development executive vice-president and chief medical officer Sean Bohen 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.
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"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."
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By GlobalDataThe approval is based on data from two Phase II trials (AURA extension and AURA2) and the AURA Phase I expansion trial, which showed efficacy in 474 patients with EGFRm T790M NSCLC who had progressed on or after an EGFR-TKI.
In the combined Phase II trials, the objective response rate (ORR) was 66% and progression-free survival (PFS) was 9.7 months, while in the Phase I trial ORR was 62% and PFS was 11 months.
Global Lung Cancer Coalition chair Dr Matthew Peters said: "It is an exciting time in the care of patients with lung cancer. The ability to precisely characterise 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 tumour 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 follows US Accelerated Approval granted in November last year and availability in the UK under the Early Access to Medicines Scheme last December.
Osimertinib was also granted priority review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), while interactions with other regulatory authorities in the rest of the world are ongoing.
