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Published on 1 July 2009

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AstraZeneca’s Iressa approved in Europe

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AstraZeneca announced today that the European Commission has grantedmarketing authorisation for the oral anti-cancer drug, IRESSA for thetreatment of adults with locally advanced or metastatic non-small celllung cancer (NSCLC) with  activating mutations of EGFR-TK (epidermalgrowth factor receptor-tyrosine kinase) across all lines of therapy.The authorisation is based on a submission package including twopivotal Phase III studies comparing IRESSA with chemotherapy, IPASS andINTEREST.

IRESSA acts by inhibiting the tyrosine kinase enzymein the EGFR, thus blocking the transmission of signals involved in thegrowth and spread of tumours. A mutation in the EGFR is acharacteristic occurring in 10-15% of lung cancers in non-Asians, andstudies have shown that these types of tumours are particularlysensitive to IRESSA.

Anders Ekblom, Executive Vice Presidentfor Development at AstraZeneca, said: “IRESSA is the first trulytargeted treatment for lung cancer, and the EU marketing authorisationtoday represents an important step forward in the treatment of thisdevastating disease. For the first time, patients with EGFR mutationpositive tumours will have a more effective and better toleratedalternative to chemotherapy as a first-line treatment.”

AstraZenecawill work closely with clinicians and pathology groups on acountry-by-country basis to facilitate appropriate access to EGFRmutation diagnostic testing.

AstraZeneca has agreed to conduct aFollow-up Measure Study to generate further data in a Caucasian NSCLCpatient population and is currently in discussion with the EMEA tofinalise the study design and endpoints.

AstraZeneca



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