ODAC to review Amgen’s Nplate, ESAs

Executive Summary

FDA's Oncologic Drugs Advisory Committee will meet March 12-13 to review the cumulative data, including recent study results, on the risk of erythropoeisis-stimulating agents in patients with cancer and to consider the BLA for Amgen's platelet producer Nplate (romiplostim). Discussion regarding the safety of ESAs will focus on Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit as well as Roche's Mircera, FDA says in the Jan. 25 Federal Register. At the last ODAC review of ESA safety, the panel recommended that sponsors conduct additional trials to support continued marketing in the oncology setting (1"The Pink Sheet" May 14, 2007, p. 3)...