IRESSA receives CHMP positive opinion to include blood based diagnostic testing in Euro label

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update* to the European label for IRESSA® (gefitinib).


The label update will help doctors to identify lung cancer patients - based on the specific genetic drivers of their tumour - who could benefit from treatment with IRESSA but are unable to provide a suitable tumour sample.

IRESSA is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) indicated for the first line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of the EGFR tyrosine kinase. Therefore, only patients whose tumours are EGFR mutation positive are eligible to receive treatment. Tumour samples gained through biopsy are the primary method for determining a patient’s EGFR mutation status, without which patients are not eligible for treatment with an EGFR TKI such as IRESSA, which is the standard of care in Europe. However, up to 25 percent of patients with locally advanced or metastatic NSCLC do not have an available or evaluable tumour sample for this method of testing.

Following today’s CHMP opinion, IRESSA will be the first EGFR TKI in Europe to have a label allowing the use of circulating tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option. The update will take effect immediately and will be applicable in all 28 European Union member countries.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said: “At AstraZeneca, we are committed to developing targeted medicines that improve health outcomes for patients. Understanding the nature of an individual’s tumour 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 tumour, 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 has pioneered the use of innovative blood-based diagnostic testing for solid tumours and recently announced a partnership with Qiagen to develop a ctDNA test as a companion diagnostic for IRESSA.

*The CHMP positive opinion to include blood based testing to determine EGFR mutation status in IRESSA’s European label can be implemented without further approval by the EMA due to the nature of the amendment, which is a Type-II variation.


IRESSA is a targeted monotherapy for the first line treatment of patients with advanced or metastatic EGFR mutation positive non-small cell lung cancer (NSCLC). IRESSA acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumours. EGFR mutations occur in approximately 10-15 percent of NSCLC patients in Europe and 30-40 percent of NSCLC patients in Asia.

IRESSA was launched in 2009 and is now approved in 89 countries worldwide.

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