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Importance of Pharmacogenetics in Oncology Richard Pazdur, MD. Director Office of Oncology Drug Products Center for Drug Evaluation and Research Food and.

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Presentation on theme: "Importance of Pharmacogenetics in Oncology Richard Pazdur, MD. Director Office of Oncology Drug Products Center for Drug Evaluation and Research Food and."— Presentation transcript:

1 Importance of Pharmacogenetics in Oncology Richard Pazdur, MD. Director Office of Oncology Drug Products Center for Drug Evaluation and Research Food and Drug Administration

2 Integrating Pharmacogenetics Into Therapeutics Is An Agency-Wide Initiative “For the first time, physicians will have a chance to treat people as individuals, not as members of a “population.” We will also be able to treat patients based on the actual biology of the disease -- not just according to their symptoms.” Janet Woodcock, M.D. FDA Consumer Magazine December 2005

3 Drug Labeling: The Legal Basis of Prescribing “If evidence is available to support the safety and effectiveness of the drug only in selected subgroups of the larger population with a disease, the labeling shall describe the evidence and identify specific tests needed for selection and monitoring of patients who need the drug.” - 21 CFR 201.57

4 Presentation Outline Why do we need to optimize benefit/risk in cancer therapy? How can PG help to optimize benefit/risk in Oncology? What have we done so far in Oncology? How can we promote individualized medicine in Oncology treatment?

5 Why do we need to optimize benefit/risk in cancer therapy? Marginal Efficacy ♦ Inadequate tumor response ♦ Minimum survival benefit Serious Toxicities ♦ Hematological toxicities ♦ Non-hematological toxicities

6 How can PG help to optimize benefit/risk in Oncology? Drug Development Candidate selection based on genetic biomarkers Develop dose/concentration-response relationship Patient selection in clinical trial Dose selection for a subpopulation

7 How can PG help to optimize benefit/risk in Oncology? Drug Approval and Label Provide evidence for effectiveness and safety Tailor dose for special population Recommend monitoring for safety

8 What have we done so far? Drugs/Biologics approved for a specific population Gleevec Herceptin Erbitux Penitumumab Rituxan

9 What have we done so far in Oncology? Modified dose for patients with variant genotype Purinethol (6-mercaptopurine) Camptosar (irinotecan)

10 What do we need to do for personalized medicine in Oncology treatment? Develop Potential Targets/Biomarkers Co-develop drug-test with CDRH Diagnosis and Staging Identify Responders Include PG information in the Package Insert

11 Washington Watch FDA Spades Field of Personalized Medicine “We are discovering so much about disease such as cancer at the molecular level,” Andrew von Eschenbach, MD, told a national television audience, vowing that the FDA would help to quickly and safely get targeted therapies to subpopulations needing them. Biotechnology Healthcare, February 2006

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