Published in:
Open Access
01-12-2014 | Review
Clinical pharmacology of tyrosine kinase inhibitors becoming generic drugs: the regulatory perspective
Authors:
Niels Eckstein, Lea Röper, Bodo Haas, Henrike Potthast, Ulrike Hermes, Christoph Unkrig, Frauke Naumann-Winter, Harald Enzmann
Published in:
Journal of Experimental & Clinical Cancer Research
|
Issue 1/2014
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Abstract
Over the last decades, billions have been spent and huge efforts have been taken in basic and clinical cancer research [CA Cancer J Clin 63: 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.