"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. "Amgen is working diligently with the FDA to initiate prospective studies that address ongoing questions regarding survival when ESAs are used according to the current prescribing information."
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. The overall survival results corroborate an earlier review by the Cochrane Collaboration, published in 2006, which is included in the WARNINGS section of the current U.S. prescribing information (HR: 1.08 [95 percent CI 0.99-1.18]). ESAs increased on-study deaths (HR: 1.17 [95 percent CI 1.06 -- 1.30]) and decreased overall survival (HR: 1.06 [95 percent CI 1.00 -- 1.12]) compared to controls.
The analyses on patients undergoing chemotherapy, the cancer indication for which ESAs are approved, were based on 38 studies with 10,441 patients. None of these studies utilized ESAs according to current label guidance. ESAs increased on-study deaths (HR: 1.10 [95 percent CI 0.98 -- 1.24]) and decreased overall survival (HR: 1.04 [95 percent CI 0.97 -- 1.11]) compared to controls. While neither of these results is statistically significant, they do not exclude the potential for adverse outcomes when ESAs are used according to the current label.
Amgen believes these results emphasize the importance of adherence to the current ESA labeling, which details these and other risks. To decrease these risks, physicians should use the lowest ESA dose needed to avoid red blood cell transfusion, and only for treatment of anemia due to concomitant myelosuppressive chemotherapy. ESAs are not indicated for cancer patients receiving myelosuppressive therapy when the anticipated outcome of such therapy is cure.
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. In the meantime, physicians and patients should review the patient Medication Guide and prescribing information in order to make informed treatment decisions based on each patient's unique clinical profile.
To enable a comprehensive analysis of existing data, Amgen, Johnson & Johnson Pharmaceutical Research & Development, Roche and independent investigators submitted patient-level data from randomized, controlled clinical studies of ESAs involving approximately 14,000 patients to the Cochrane Collaboration. Complete results of this independent review of ESA treatment outcomes are expected to be presented at a scientific conference by the Cochrane Collaboration later this year.
About The Cochrane Collaboration
The Cochrane Collaboration is an international not-for-profit and independent organization, dedicated to making up-to-date, accurate information about the effects of healthcare readily available worldwide. It produces and disseminates systematic reviews of healthcare interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions.
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