AstraZeneca cancer drug use curtailed

AstraZeneca was dealt a serious blow yesterday when use of its new cancer drug was curtailed by the Japanese health authorities.

Iressa, a novel treatment for lung cancer so far only available in Japan, has been subject of growing safety concerns since it was launched in the summer. There have been nearly 500 suspected cases of side effects, and the drug has been linked to 124 deaths from a form of pneumonia.

AstraZeneca, the UK's second largest drugmaker, continues to insist the side effect profile since the drug was launched is no different to that seen in clinical trials. It says the drug is useful for cancer patients in whom all other treatments have failed.

Yesterday, the Japanese health ministry imposed stricter controls on the use of Iressa. Only doctors experienced in treating lung cancer patients will be able to prescribe the drug from today, and patients will have to remain in hospital for at least four weeks after beginning to take it.

The ministry is also restricting the use of Iressa to medical institutions capable of treating patients with sudden side effects, meaning only large hospitals will be able to use it.

The changes were recommended by a panel of experts set up to examine the benefits and side effects of the drug. Almost 19,000 Japanese citizens are using Iressa.

Regulators in the US, the largest drug market in the world, are yet to approve the drug.

Iressa targets proteins produced only by cancer cells and does not cause the nausea and hair-loss of chemotherapy. It is currently only being used as a last line of defence, however, since it has proved to be innefective when used in combination with chemotherapy.

The product is expected to have sales of up to £350m a year, much less than once hoped, but it remains a key plank in AstraZeneca's strategy for replacing sales of Losec, its giant selling ulcer drug, which is facing copycat competition in the United States.