[Clinical development of antitumor agent in Europe and USA--experience on CPT-11 development]

Irinotecan hydrochloride (CPT-11) was approved first in Japan in January 1994, then in France in May 1995 and in the USA in June 1996. These approvals were given based on Japanese non-clinical data and the clinical data from phase I and II studies conducted independently in each country. It took almost 3 years in Japan to gain approval; however, six months were sufficient for approval in France and the USA. Systems are well established in Europe and the USA for clinical studies and the development of antitumor agents. It appears that, in Europe and the USA, cancer patients are well supported by society and that cancer chemotherapies are well understood in society as well.