EPO at ODAC

Johnson & Johnson and Amgen have been invited to FDA's May 10 Oncologic Drugs Advisory Committee meeting to discuss the effects of EPO products on survival and tumor progression in cancer patients. Both J&J's Procrit (epoetin alfa) and Amgen's Aranesp (darbepoetin alfa) will receive updated labeling to include a boxed warning that will apply to both oncology and nephrology indications for all erythropoiesis-stimulating agents. The boxed warning comes after safety concerns based on recent data related to increased risk of death and cardiovascular outcomes (1"The Pink Sheet" Jan. 29, 2007, p. 9). Roche, which submitted a BLA for its continuous erythropoietin receptor activator Mircera, says it has not been invited to participate in the ODAC meeting...

Johnson & Johnson and Amgen have been invited to FDA's May 10 Oncologic Drugs Advisory Committee meeting to discuss the effects of EPO products on survival and tumor progression in cancer patients. Both J&J's Procrit (epoetin alfa) and Amgen's Aranesp (darbepoetin alfa) will receive updated labeling to include a boxed warning that will apply to both oncology and nephrology indications for all erythropoiesis-stimulating agents. The boxed warning comes after safety concerns based on recent data related to increased risk of death and cardiovascular outcomes (¹ (Also see "Aranesp Anemia Of Cancer Study Results Show Increased Mortality Risk" - Pink Sheet, 29 Jan, 2007.), p. 9). Roche, which submitted a BLA for its continuous erythropoietin receptor activator Mircera , says it has not been invited to participate in the ODAC meeting....