Iressa label update allows circulating tumour DNA to assess EGFR mutation status - AstraZeneca

AstraZeneca 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.

Following the 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.

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.