Aranesp/Procrit Trial Tumor Biopsy Collection Not Feasible, Cmte. Says
Executive Summary
Amgen's and Johnson & Johnson's erythropoietin survival studies cannot logistically include a tumor biopsy component, FDA's Oncologic Drugs Advisory Committee said May 4
You may also be interested in...
Amgen Wins Supreme Court Review Of EPO Securities Fraud Class Certification
The court will decide whether a party seeking class certification must show that a company’s alleged misrepresentations are material; investors claim Amgen misrepresented the safety of Aranesp and Epogen prior to a May 2004 FDA advisory committee meeting.
EPO Dosing Questions Left Unanswered; More Data, More Meetings Needed
Amgen does not currently have enough data to characterize the relationship between targeted hemoglobin levels in patients receiving erythropoiesis-stimulating agents and clinical outcomes in the oncologic setting
EPO Scathed But Survives ODAC Challenge; Cmte. Calls For Additional Trials
Sponsors of erythropoiesis-stimulating agents should conduct additional safety studies to support continued marketing in the oncology setting, FDA's Oncologic Drugs Advisory Committee unanimously recommends