IRESSA (Gefitinib) Recommended for Approval for the Treatment of Non-Small Cell Lung Cancer in Europe

Thursday, 23 April 2009

AstraZeneca announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory committee of the European Medicines Agency (EMEA), has issued a positive opinion supporting approval of the targeted oral anti-cancer drug, IRESSA (gefitinib).

The CHMP has recommended the approval of IRESSA for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase), in all lines of therapy.

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. A mutation in the EGFR is a characteristic occurring in 10-15% of lung cancers in Europe, and studies have shown that these types of tumours are particularly sensitive to IRESSA. There are approximately 106,000 new cases of advanced lung cancer in Europe (top 5 countries) per year.

Anders Ekblom, Executive Vice President for Development at AstraZeneca, said: "Today’s positive CHMP opinion on IRESSA is an important step towards addressing the great unmet medical need of lung cancer patients in Europe, and supports AstraZeneca’s personalised healthcare strategy to develop the right medicine for the right patient. If IRESSA is approved, for the first time patients with these types of tumours will have a better alternative to chemotherapy as a first-line treatment.”

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

The IPASS study exceeded its primary objective, demonstrating superior progression-free survival (PFS, the time a patient lives without their cancer progressing), greater objective response rate (ORR, tumour shrinkage), improved tolerability and significant quality of life benefits for IRESSA compared to carboplatin/paclitaxel doublet chemotherapy in clinically selected first-line patients in Asia. However, the treatment effect was not constant over time, with the probability of being progression-free in favour of carboplatin/paclitaxel in the first 6 months and in favour of IRESSA in the following 16 months. This was likely due to the different effect of IRESSA in subgroups defined by EGFR tumour mutation status. PFS was significantly longer for IRESSA than doublet chemotherapy in patients with EGFR mutation positive tumours, and significantly longer for doublet chemotherapy than IRESSA in patients with EGFR mutation negative tumours.

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

AstraZeneca will be required to conduct a Follow-up Measure Study, to generate further data in a Caucasian NSCLC patient population. AstraZeneca is in discussion with the CHMP to finalise the study design and endpoints.

The CHMP positive opinion is now referred for final action to the European Commission, which grants marketing approval in the European Union.

IRESSA is already an established therapy for pre-treated NSCLC in the Asia-Pacific region, where AstraZeneca is in consultation with regulatory authorities to discuss the potential use of IRESSA in first-line therapy.


In 2005, AstraZeneca withdrew its EU marketing authorisation application for IRESSA following data from the Phase III international ISEL study in pre-treated patients not eligible for further chemotherapy. ISEL did not meet its primary objective of a statistically significant improvement in OS for IRESSA compared to placebo, but did confirm a number of important clinical benefits for IRESSA including tumour shrinkage and a significant improvement in time to treatment failure. The refractory* nature of the ISEL population is the most likely explanation for the magnitude of the survival improvement with IRESSA compared to placebo not reaching statistical significance.

* Patients whose tumours had grown during or soon after receiving prior chemotherapy

Following delivery of the INTEREST data, AstraZeneca submitted a new regulatory package to the EMEA in May 2008; the IPASS data were added to the submission package when they became available in Q3 2008.

There is a rolling programme of approvals and licence updates for IRESSA around the world in a broad second-line population based on data from the INTEREST study.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit:


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