Amgen receives executive summary on independent review of ESAs in oncology
Dated: 10/8/2008
Amgen says it has received a summary of preliminary results from the Cochrane Collaboration's independent meta-analysis of patient-level data from previously conducted, randomized, controlled, clinical studies evaluating erythropoiesis-stimulating agents (ESAs) in cancer patients.
Amgen has submitted the executive summary to regulatory authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA).
"The Cochrane Collaboration's analysis corroborates important information already reflected in the recently revised ESA labeling, which physicians and patients should consider when making individual treatment decisions," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.
The preliminary summary includes four components: on-study deaths and overall survival in cancer patients regardless of their specific cancer treatment (chemotherapy, radiochemotherapy, radiotherapy, anemia of cancer with no treatment, other), and on-study deaths and overall survival in patients receiving chemotherapy (the only population for which ESA treatment is indicated in current FDA-approved labeling).
The analyses on all cancer patients were based on 53 previously conducted studies involving 13,933 patients.
None of these studies utilized ESAs according to current label guidance.
Amgen is working with the FDA to finalize the risk evaluation and management strategy (REMS) for ESAs, which will ensure that these and other risks are communicated to physicians and patients.
