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Update on the Safety of Erythropoietin Products in Patients With Cancer. May 4, 2004 Robert DeLap, MD, PhD Vice President, Global Regulatory Affairs Johnson & Johnson Pharmaceutical Research & Development. Background Chemotherapy-associated Anemia. Chemotherapy frequently causes anemia

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Update on the Safety of Erythropoietin Products in Patients With Cancer


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update on the safety of erythropoietin products in patients with cancer

Update on the Safety of Erythropoietin Products in Patients With Cancer

May 4, 2004

Robert DeLap, MD, PhD

Vice President, Global Regulatory Affairs

Johnson & JohnsonPharmaceutical Research & Development

background chemotherapy associated anemia
BackgroundChemotherapy-associated Anemia
  • Chemotherapy frequently causes anemia
    • Debilitating symptoms, may require transfusion
  • Erythropoietin products valuable alternative to transfusion
    • Patient benefits
    • Conservation of blood supply
    • Demonstrated safety profile in multiple indications
  • Extensive clinical experience
    • Epoetin alfa—widely studied
    • Over 2 million patients with cancer treated with PROCRIT® and EPREX®
definitions
Definitions
  • Supportive anemia care: studies evaluating the established indication, treatment of anemia
    • Goal is to obtain sufficient rise in hemoglobin to reduce need for transfusion
  • Beyond correction of anemia: investigational studies treating to higher hemoglobin levels
    • Includes most of the recent studies evaluating effects of erythropoietic agents on cancer treatment outcomes (response, progression, survival)
safety data to be presented
Safety Data to Be Presented
  • In supportive anemia care, data and extensive clinical experience support the favorable benefit/risk profile of epoetin alfa
  • In some investigational studies of erythropoietin products used beyond correction of anemia, evidence of increased risk has been observed
  • Additional data are being collected, and further research is under consideration
today s agenda
Today’s Agenda

Evaluation of Studies Dr. Peter Bowers

  • Supportive Anemia Care
  • Beyond Correction of Anemia

Future Clinical Data Dr. Martine George

Conclusions Dr. Martine George