Clinical pharmacology of tyrosine kinase inhibitors becoming generic drugs: the regulatory perspective

Journal of Experimental & Clinical Cancer Research

Harald Enzmann¹  Frauke Naumann-Winter¹  Christoph Unkrig¹  Ulrike Hermes¹  Henrike Potthast¹  Bodo Haas¹  Lea Röper¹  Niels Eckstein¹ 

[1] Federal Institute of Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, Bonn 53175, Germany

关键词: Orphan drug status;    Tyrosine kinase inhibitors (TKI);    Narrow therapeutic index drugs (NTID);   

Others  :  804514
DOI  :  10.1186/1756-9966-33-15

 received in 2014-01-27, accepted in 2014-02-03,  发布年份 2014

【 摘 要 】

Over the last decades, billions have been spent and huge efforts have been taken in basic and clinical cancer research [CA Cancer J Clin63:11-30]. About a decade ago, the arms race between drugs and cancer cells reached a new level by introduction of tyrosine kinase inhibitors (TKI) into pharmacological anti-cancer therapy. According to their molecular mechanism of action, TKI in contrast to so-called “classic” or “conventional” cytostatics belong to the group of targeted cancer medicines, characterized by accurately fitting with biological structures (i.e. active centers of kinases). Numerous (partly orphan) indications are covered by this new class of substances. Approximately ten years after the first substances of this class of medicines were authorized, patent protection will end within the next years. The following article covers clinical meaning and regulatory status of anti-cancer TKI and gives an outlook to what is expected from the introduction of generic anti-cancer TKI.

【 授权许可】

   
2014 Eckstein et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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