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[Development of new anti-cancer agents in Europe]
1Yakult Honsha Co., Ltd., Medicine Department, Japan.
Abstract:
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.
Insights
Irinotecan (CPT-11), a derivative of camptothecin, received marketing approval in 1994 for lung, cervical, and ovarian cancers. Further development led to its approval for advanced colon cancers in France in 1995.
Area of Science:
- Oncology
- Pharmacology
- Clinical Development
Background:
- Camptothecin, the parent compound of Irinotecan (CPT-11), was initially discontinued by the NCI (USA).
- Irinotecan (CPT-11) emerged as a significant anticancer agent, developed 12 years after camptothecin's discontinuation.
- The development timeline highlights the iterative nature of drug discovery and refinement in oncology.
Purpose of the Study:
- To detail the clinical development and regulatory approval pathway of Irinotecan (CPT-11).
- To discuss the progression of Irinotecan (CPT-11) from initial synthesis to market authorization for various cancer indications.
- To provide context on the clinical development of novel anticancer agents, specifically within the French regulatory landscape.
Main Methods:
- Review of clinical trial phases (Phase I and Phase II) for Irinotecan (CPT-11).
- Analysis of new drug application filings and marketing approval processes in the USA and France.
- Examination of the timeline for initiating and completing clinical studies across different geographical regions (Japan, France).
Main Results:
- Irinotecan (CPT-11) received marketing approval in 1994 in the USA for non-small cell lung cancer, small cell lung cancer, cervical cancer, and ovarian cancer.
- Phase I clinical studies in France commenced in 1990, following late Phase II studies in Japan.
- Marketing approval for advanced colon cancers in France was granted in May 1995, after Phase II studies.
Conclusions:
- Irinotecan (CPT-11) demonstrated a successful development trajectory, leading to approvals for multiple cancer types.
- The drug's development showcases international collaboration and phased regulatory submissions.
- The discussion underscores the evolving landscape of anticancer drug development and approval processes.