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* Positive opinion for Iressa in EGFR-positive patients

* Move revives hopes for drug largely written off

* Iressa failed undifferentiated Phase III study in 2004

* EU decision underscores shift to personalised medicine

By Ben Hirschler

LONDON, April 23 (Reuters) - AstraZeneca Plc's (AZN.L) Iressa should be approved for certain lung cancer patients, European regulators said on Thursday, reviving fortunes for a product largely written off by analysts.

A European Medicines Agency expert panel issued a positive opinion supporting Iressa as a treatment for adults with locally advanced or metastatic non-small cell lung cancer, whose tumours have an EGFR mutation.

Epidermal growth factor receptor, or EGFR, is a molecule tumours use to grow themselves blood supplies.

Iressa, a once-a-day pill, is on sale in Japan but has never made inroads in other markets, following its failure to show significant benefits in the overall population of lung cancer patients in a Phase III clinical study in December 2004.

Its comeback could pose a threat to Tarceva, another oral lung cancer treatment from OSI Pharmaceuticals Inc (OSIP.O) and Roche Holding AG (ROG.VX).

Recommendations for marketing approval by the European agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

The endorsement of Iressa's use in a small sub-set of lung cancer patients reflects a growing trend to more personalised treatment in cancer, as therapies are increasingly tailored to individuals' genetic profiles.

A mutation in the EGFR molecule is a characteristic occurring in 10 percent to 15 percent of lung cancers in Europe, and studies have shown these types of tumours are particularly sensitive to Iressa.

"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," said Anders Ekblom, executive vice president for development at AstraZeneca.

AstraZeneca will be required to conduct a further follow-up study, to generate more data on the drug's effectiveness in a Caucasian population and the company said it was in discussion with the CHMP to finalise the study design.

Iressa was once viewed as a likely blockbuster for the Anglo-Swedish group, but its failure in 2004 dealt a major blow to the product and it has since been seen by analysts as a niche medicine for use in Asia. (Editing by Andrew Macdonald)

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