A Health, Labor and Welfare Ministry study group offered its final opinion Thursday that AstraZeneca PLC\'s lung cancer drug Ire a continue to be administered in Japan de ite a major clinical test overseas failing to confirm that the agent hel to significantly increase the survival rate of patients.
Analyses of a large-scale clinical test conducted by the British firm in 28 countries, excluding Japan, last December showed the drug failed to significantly prolong the life of patients but suggested survival benefits for Asia .
Ire a, marketed in Japan by AstraZeneca K.K., the Japanese su idiary of the British drug maker, has arked controversy after it became known in 2002 that a number of people in Japan had died from its side effects.
As of the end of last year, nearly 600 patients in Japan had died from such illne es as intestinal eumonia, believed to be a side effect of the drug.
The drug was a roved for use in Japan in July 2002 after an unusually fast screening proce . Japan was the first country to import the drug.
The ministry, however, i ued a warning in October 2002 in re o e to the growing number of deaths linked to Ire a.
The study group, led by Kazunori Matsumoto, a profe or at the International University of Health and Welfare, urged in the opinion that the state see to it that the Japan Lung Cancer Society\'s revised guideline be co ulted when using the drug, generically known as gefitinib.
The guideline recommends that the agent be administered to patients deemed prone to react well to it based on tests.
The Japan Times: March 25, 2005