FDA Clinical Pharmacology Advisory Committee

1
FDA Clinical Pharmacology Advisory Committee

• October 18th, 2006
• David A Flockhart MD, PhD
• Indiana University School of Medicine

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Implications of a CYP2D6 test for tamoxifen

• Change in drug selection is under consideration,
  not dose.
• Alternatives to tamoxifen are available in
  post-menopausal women.
• Relevance to formularies
• An effect of genetics on efficacy involves
  different considerations than previously
  considered predicted toxicities
• mercaptopurines
• irinotecan
• warfarin

3

• Germline DNA as a test in breast cancer.
• Not somatic like Herceptin, Estrogen and
  Progesterone receptor.
• CYP2D6 pharmacogenetics are relevant to many
  other drugs metabolized by it.
• Many labels incorporate description of the
  polymorphism already
• None define drug selection by genotype