title: Functional differentiation of cytotoxic cancer drugs and targeted cancer therapeutics.
abstract: There is no nationally or internationally binding definition of the term "cytotoxic drug" although this term is used in a variety of regulations for pharmaceutical development and manufacturing of drugs as well as in regulations for protecting medical personnel from occupational exposure in pharmacy, hospital, and other healthcare settings. The term "cytotoxic drug" is frequently used as a synonym for any and all oncology or antineoplastic drugs. Pharmaceutical companies generate and receive requests for assessments of the potential hazards of drugs regularly - including cytotoxicity. This publication is intended to provide functional definitions that help to differentiate between generically-cytotoxic cancer drugs of significant risk to normal human tissues, and targeted cancer therapeutics that pose much lesser risks. Together with specific assessments, it provides comprehensible guidance on how to assess the relevant properties of cancer drugs, and how targeted therapeutics discriminate between cancer and normal cells. The position of several regulatory agencies in the long-term is clearly to regulate all drugs regardless of classification, according to scientific risk based data. Despite ongoing discussions on how to replace the term "cytotoxic drugs" in current regulations, it is expected that its use will continue for the near future.
authors: Novartis Pharma AG NIBR, Postfach, CH-4002 Basel, Switzerland. Electronic address: gian_christian.winkler@novartis.com.
authors: Gian C
authors: GC
authors: Winkler
authors: Novartis Pharma AG, Postfach, CH-4002 Basel, Switzerland. Electronic address: ester.lovsin_barle@novartis.com.
authors: Ester Lovsin
authors: EL
authors: Barle
authors: Patheon Inc., 2100 Syntex Court, Mississauga, Ontario L5N 7K9, Canada. Electronic address: joe.galati@patheon.com.
authors: Giuseppe
authors: G
authors: Galati
authors: Novartis Pharmaceuticals Corporation, NIBR, One Health Plaza, East Hanover, NJ 07936-1080, USA. Electronic address: william.kluwe@novartis.com.
authors: William M
authors: WM
authors: Kluwe
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000494:pharmacology; D004345:Drug Industry; D006801:Humans; D058990:Molecular Targeted Therapy; D009369:Neoplasms / Q000188:drug therapy*; D016273:Occupational Exposure / Q000517:prevention & control; D004364:Pharmaceutical Preparations / Q000145:classification; D009626:Terminology as Topic
chemical_list: D000970:Antineoplastic Agents; D004364:Pharmaceutical Preparations
keywords: Antineoplastic drugs; Cytotoxic cancer drugs; Drug development; Functional definition; Occupational health; Pharmaceutical manufacturing; Selective oncology drugs; Targeted therapeutics