Cancer drug 'supplied before approval given'

Pharmaceutical giant AstraZeneca illegally supplied the cancer-fighting drug Gefitinib to doctors in Japan more than a year before the government had approved its use, Japan’s largest newspaper reported today.

The Anglo-Swedish company began offering the drug free of charge to doctors at 89 clinics and hospitals in December 2000 – three months before clinical trials ended – and 286 lung cancer patients took it, the Yomiuri newspaper said, citing unidentified sources.

Officials at AstraZeneca’s offices in the city of Osaka were not immediately available for comment.

Gefitinib was cleared for use in Japan in July. Since its approval, at least 10,000 cancer patients have taken the drug, but the drug’s side effects have been blamed for 124 deaths, according to the health, labour and welfare ministry.

The dead were among 494 patients who have developed debilitating lung disorders including interstitial pneumonia blamed on the drug, the ministry said.

In October, the drug manufacturer said Gefitinib had caused 39 deaths.

Japan is the only country to approve Gefitinib as treatment for advanced non-small cell lung cancer. It is sold in Japan under the Iressa brand.

The US Food and Drug Administration and Swiss health authorities are reviewing AstraZeneca’s application to sell the drug.

Early studies showed lung cancer patients who had not been helped by other therapy recovered impressively after taking Iressa, but the large number of severe side effects prompted AstraZeneca to issue a safety warning to Japanese doctors in October.

The Yomiuri said all patients who were given the drug before approval had not responded to other therapies.