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Published on 27 April 2009

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Iressa recommended for approval


AstraZeneca announced today that the Committee for MedicinalProducts for Human Use (CHMP), the scientific advisory committee of theEuropean Medicines Agency (EMEA), has issued a positive opinionsupporting approval of the targeted oral anti-cancer drug, Iressa(gefitinib).

The CHMP has recommended the approval of Iressafor adults with locally advanced or metastatic non-small cell lungcancer (NSCLC) with activating mutations of EGFR-TK (epidermal growthfactor receptor-tyrosine kinase), in all lines of therapy.

Iressaacts by inhibiting the tyrosine kinase enzyme in the EGFR, thusblocking the transmission of signals involved in the growth and spreadof tumours. A mutation in the EGFR is a characteristic occurring in10-15% of lung cancers in Europe, and studies have shown that thesetypes of tumours are particularly sensitive to Iressa. There areapproximately 106,000 new cases of advanced lung cancer in Europe (top5 countries) per year.

Anders Ekblom, executive vice presidentfor development at AstraZeneca said: “Today’s positive CHMP opinion onIressa is an important step towards addressing the great unmet medicalneed of lung cancer patients in Europe, and supports AstraZeneca’spersonalised healthcare strategy to develop the right medicine for theright patient. If Iressa is approved, for the first time patients withthese types of tumours will have a better alternative to chemotherapyas a first-line treatment.”

The CHMP opinion is based on a submission package including two pivotal phase III studies, IPASS and INTEREST.

TheIPASS study exceeded its primary objective, demonstrating superiorprogression-free survival (PFS, the time a patient lives without theircancer progressing), greater objective response rate (ORR, tumourshrinkage), improved tolerability and significant quality of lifebenefits for Iressa compared to carboplatin/paclitaxel doubletchemotherapy in clinically selected first-line patients in Asia.

However, the treatment effect was not constant over time with theprobability of being progression-free in favour ofcarboplatin/paclitaxel in the first 6 months and in favour of Iressa inthe following 16 months. This was likely due to the different effect ofIressa in subgroups defined by EGFR tumour mutation status.

PFS wassignificantly longer for Iressa than doublet chemotherapy in patientswith EGFR mutation positive tumours, and significantly longer fordoublet chemotherapy than Iressa in patients with EGFR mutationnegative tumours.

The INTEREST study met its primary objective,demonstrating equivalent overall survival (OS) and significant qualityof life benefits for Iressa compared to standard chemotherapy(docetaxel) in the pre-treated setting. Pre-planned sub-group analysesshowed a significant improvement in PFS and ORR for Iressa overdocetaxel in patients with EGFR mutation positive tumours.

AstraZenecawill be required to conduct a follow-up measure study, to generatefurther data in a Caucasian NSCLC patient population. AstraZeneca isin discussion with the CHMP to finalise the study design and endpoints.

TheCHMP positive opinion is now referred for final action to the EuropeanCommission, which grants marketing approval in the European Union.

Iressais already an established therapy for pre-treated NSCLC in theAsia-Pacific region, where AstraZeneca is in consultation withregulatory authorities to discuss the potential use of Iressa infirst-line therapy.


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