AstraZeneca's EU Label Update For Iressa Backed By CHMP

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave its positive recommendation for a Type 2 variation update to the EU label of AstraZeneca’s Iressa (gefitinib) to include blood-based diagnostic testing.

Iressa is a targeted monotherapy indicated as first line treatment for advanced or metastatic EGFR mutation positive non-small cell lung cancer (NSCLC). The drug inhibits the tyrosine kinase enzyme in the EGFR and blocks the signal transmission involved in tumor growth and metastasis. Mutations in EGFR takes place in an estimated 10 to 15 percent of patients with NSCLC in the EU and around 30 to 40 percent of patients in Asia. Iressa is currently approved in nearly 90 countries around the world.

The update will assist physicians in determining which patients with lung cancer will best benefit from Iressa based on their tumor’s genetic drivers, but who are unable to adequately supply a tumor sample. Up to 25 percent of patients with locally advanced or metastatic NSCLC are unable to provide an available or assessable sample for biopsy testing.

Briggs Morrison, EVP of Global Medicines Development and CMO at AstraZeneca said, “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.”

Being a variation of a Type 2 label update, the CHMP opinion needs no further approval from the EMA. AstraZeneca stated that the update will be immediately implemented and will be effective in all 28 member countries of the European Union.

In July, AstraZeneca established a partnership with QIAGEN to develop a companion diagnostic ctDNA test for Iressa.