AstraZeneca announced a Type II update to the European label for Iressa (gefitinib) that allows doctors to identify suitable lung cancer patients for treatment with this drug even in the absence of a tumor sample. The positive avowal was emitted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) commonly have mutations in the epidermal growth factor receptor (EGFR) tyrosine kinase. Iressa is an inhibitor of this receptor and the first-line treatment for NSCLC patients, which renders it crucial to confirm the mutational status of a patient’s tumor before initiating therapy with Iressa or other EGFR tyrosine kinase inhibitors. However, tumor sampling from advanced or metastatic NSCLC is inaccessible in approximately 25% of these patients.
Now, the update introduced to Iressa in all European Union countries, allows for circulating tumor DNA (ctDNA), obtained with a regular collected blood sample, to be used for assessment of the EGFR mutation status, whenever tumor sampling is inaccessible.
Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca commented in a company’s press release, “At AstraZeneca, we are committed to developing targeted medicines that improve health outcomes for patients. Understanding the nature of an individual’s tumor and therefore which medicine is most likely to benefit them is vital if we are to transform the way cancer patients are treated. If doctors are unable to assess the mutation status of a tumor, then patients’ access to potentially life-changing medicines such as Iressa becomes restricted. Today’s decision by the CHMP to endorse a label update for Iressa is a significant step forward.”
AstraZeneca is a leading company for the use of blood collected samples to diagnose tumor parameters and will now develop, together with Qiagen a ctDNA test to be used with Iressa.