European Commission Grants Conditional Marketing Authorization to AstraZeneca

February 3, 2016
Pharmaceutical Technology Editors

AstraZeneca received conditional marketing authorization for Tagrisso, a tablet for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer.

AstraZeneca received conditional marketing authorization for Tagrisso, a tablet for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer.

AstraZeneca announced on Feb. 3, 2016 that the European Commission (EC) has granted conditional marketing authorization for Tagrisso (AZD9291, osimertinib) 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).

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.

“It is an exciting time in the care of patients with lung cancer,” said Matthew Peters, chair of the Global Lung Cancer Coalition, in the press release. “The ability to precisely characterize 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 sensitizing 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.”

Mutations in the EGFR receptor can lead to uncontrolled cell growth and tumor formation. Osimertinib targets both the EGFR mutation that triggers cancer development and T790M, a mutation that makes tumors resistant to existing treatment with EGFR-TKIs. According to the company, nearly two out of three patients with NSCLC whose disease progresses after treatment with an EGFR inhibitor develop the T790M mutation, for which treatment options are limited. A small number of patients (approximately 3-5%) have the T790M mutation at NSCLC diagnosis.

The EU 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 (PMDA). Interactions with regulatory authorities in the rest of the world are ongoing.

Source: AstraZeneca