Given accelerated approval in 1996, the chemotherapy drug irinotecan (Camptosar) can attack metastatic colorectal cancers that don't respond to other drugs. However, by 2004 a series of studies had suggested that the drug was particularly toxic in a subset of patients homozygous for a polymorphism of
In November 2004, a Food and Drug Administration (FDA) subcommittee met with Pfizer to discuss the results, and the company is now in discussions with the regulatory agency and may update the drug's labeling.
In the future, such so-called pharmacogenetic data may be known long before a drug ever comes to market. The National Institutes of Health, through the Pharmacogenetics Research Network ...
