[Development of new anti-cancer agents in Europe].

CPT-11 was synthesized 12 years after its mother compound, camptothecin, had been dropped from development by NCI (USA). A new drug application with CPT-11 was filed in 1991 after phase I and phase II clinical studies, and the marketing approval was authorized in 1994 with indications of non-small cell and small cell lung cancers, cervical cancers, and ovarian cancers. Phase I studies in France were initiated in 1990 one year after late phase II studies were started in Japan. A new drug application was filed in 1994 after phase II studies and marketing approval was authorized by the French government in May, 1995 with indication of advanced colon cancers. Clinical development of new anticancer agents in France was discussed.