26th Sep 2014 06:37
LONDON (Alliance News) - AstraZeneca PLC said Friday that its IRESSA cancer treatment has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for an update of its European label.
This label update will help doctors to identify lung cancer patients based on the specific genetic drivers of their tumour who could benefit from IRESSA but are unable to provide a suitable tumour sample, AstraZeneca said.
After the positive opinion, IRESSA will have a label will which allow the use of circulating tumour DNA obtained from a blood sample to be used for the assessment of the epidermal growth factor receptor mutation status. The update will apply to all European Union member countries and will be applicable immediately.
"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," said Briggs Morrison, executive vice president of global medicines development and chief medical officer in a statement.
"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," Morrison added.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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