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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 May 4, 2004 Robert DeLap, MD, PhD Vice President, Global Regulatory Affairs Johnson & JohnsonPharmaceutical Research & Development
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 • 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 • 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 Evaluation of Studies Dr. Peter Bowers • Supportive Anemia Care • Beyond Correction of Anemia Future Clinical Data Dr. Martine George Conclusions Dr. Martine George