BRIDGEWATER, N.J., Feb. 26 /PRNewswire/ -- Ortho Biotech believes that the conclusions of a study published in the February 27, 2008 issue of the Journal of the American Medical Association (JAMA) by Bennett, et al, do not provide an accurate reflection of the safety profile of erythropoiesis-stimulating agents (ESAs) when used for the treatment of chemotherapy-induced anemia (CIA) in patients with cancer.
The company reaffirms that, when used according to product labeling, ESAs remain safe and effective, and are the only proven treatment alternative to blood transfusions for patients with CIA.
Ortho Biotech also provides comment on the following important topics.
Meta-Analyses
Ortho Biotech acknowledges that all meta-analyses have limitations. However, the JAMA authors recognize that a significant limitation of this analysis is that it does not analyze patient-level data from all available controlled studies with ESAs.
In a separate effort, Ortho Biotech, along with the other ESA manufacturers, has provided individual patient-level data to the independent Cochrane Collaboration to support a combined analysis of all available controlled studies with ESAs in oncology patients. This project will be the largest combined analysis of ESA safety data ever undertaken. It will create a database of more than 15,000 patients treated in various clinical studies, which should inform the benefit:risk profile of ESAs by identifying patient subgroups that would benefit from further study.
VTEs
Vascular thrombotic events (VTEs) are a well-recognized risk of ESA treatment and are prominently reflected in the labeling for all ESAs. It is important to understand that VTEs are common in cancer patients. VTEs may be underdiagnosed as a cause of death in cancer patients. For this reason, it is plausible that unrecognized VTEs are a potential explanation for increased mortality with ESAs in cancer patients, especially in those studies with high hemoglobin targets.
Mortality
Out of a total of 59 controlled studies for which mortality information has been reported, the U.S. Food and Drug Administration has characterized eight investigational studies as reporting that patients receiving ESAs had decreased overall survival and/or tumor progression compared with the control group. All eight studies were conducted in settings inconsistent with the current product label. The safety findings from these eight studies conducted outside the label have raised important questions that will be addressed through further research and risk minimization activities.
EPO Receptors
The data remain inconclusive on the hypothesis that the expression of erythropoietin receptors on tumor cells can lead to shortened survival in cancer patients. The company has proposed unrestricted funding to support independent research through the National Cancer Institute to address this hypothesis.
Ortho Biotech fully supports direction to healthcare professionals to use the lowest dose of ESAs that will gradually increase the hemoglobin concentration to a level that will avoid the need for a blood transfusion. The company believes that ESA product labeling prominently reflects all known risks of ESAs, including VTEs, when used according to the label, and increased VTEs and mortality, when used to treat beyond the correction of anemia or in cancer patients not on chemotherapy.
About PROCRIT (Epoetin alfa)
PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT
Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
Contraindications
PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.
Please visit www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients’ health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.
CONTACT: Media, Stephanie Fagan, +1-908-541-4029, or cell,
+1-201-572-9581, sfagan@obius.jnj.com, or Investors, Stan Panasewicz,
+1-732-524-2524, or Tina Pinto, +1-732-524-2034, all for Ortho Biotech
Web site: http://www.orthobiotech.com/
http://www.procrit.com/
