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Amgen to Discuss Benefits and Risks of ESA Treatment for Cancer Patients with Anemia Due to Chemotherapy at FDA ODAC Meeting
ESAs Provide Important Clinical Benefits to Cancer Patients With Anemia Due to Chemotherapy; Ongoing and Planned Risk Management Will Further Reduce Risks
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--March 13, 2008--Amgen Inc. (NASDAQ: AMGN) will today present the benefits and risks of Erythropoiesis-stimulating Agents (ESAs) in cancer patients with anemia due to concomitantly administered chemotherapy at a meeting with the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC). ESAs provide these patients with the only therapeutic alternative to red blood cell (RBC) transfusions, which have known and uncertain risks.
"ESAs provide an unequivocal treatment benefit for cancer patients undergoing chemotherapy by reducing the need for blood transfusions," said Roger M. Perlmutter, M.D., Ph.D., executive vice president, of Research and Development at Amgen. "We look forward to discussing with the ODAC a robust risk management program to reduce ESA risks while still providing access and benefits to the appropriate patients."
For a complete review and analysis of Amgen's presentation to the ODAC, Amgen's and FDA's briefing materials for the ODAC meeting are available at www.Amgen.com or www.fda.gov.
Highlights of Amgen's presentation to the ODAC will include the following:
ESA Treatment Benefits
- ESAs provide the only therapeutic alternative to RBC transfusions in cancer patients with anemia due to concomitantly administered chemotherapy.
- In well-controlled clinical trials, ESAs have been proven to reduce RBC transfusions in patients with anemia receiving chemotherapy.
- If ESAs were not available, data from Amgen's placebo-controlled clinical trials suggest that twice as many patients receiving chemotherapy would require RBC transfusions.
Risks of ESAs
- Eight ESA studies have shown safety signals when patients were studied at higher than currently labeled hemoglobin targets and/or for new experimental indications (such as radiotherapy or patients not receiving chemotherapy).
- Six of these eight studies were discussed at ODAC meetings in 2004 and 2007. Since the May 2007 ODAC meeting, new data from two studies have become available, including interim results from the PREPARE (a study in neo-adjuvant breast cancer) and long-term follow up data from GOG-191 (a study in cervical cancer), both of which targeted hemoglobin levels higher than in the current approved product label.
- These safety signals are inconsistently observed across a total of 59 studies.
- The current label notes the hypothetical risks of shortened overall survival and/or tumor progression when hemoglobin targets are less than or equal to 12 g/dL.
- Potential mechanisms for these safety signals may include thromboembolic events which have long been recognized in ESA labeling. Other mechanisms include the recently labeled but unproven hypothesis of tumor progression and reduced efficacy of radiotherapy at high hemoglobin levels.
Amgen will review the totality of clinical evidence with ODAC, including all favorable and unfavorable studies.
"Although these safety signals have been inconsistently observed across a number of ESA studies, Amgen nonetheless takes them very seriously, and is committed to conducting a controlled clinical trial based on the current label to definitively address these issues," said Perlmutter. "Patient safety is our top priority. To this end, we look forward to the ODAC's recommendations on the proposed clinical study and will continue to collaborate with the FDA, NCI and others to address these safety concerns."
Risks of Blood Transfusions
The use of blood transfusions to treat anemia carries several types of known and uncertain risks for patients with cancer and for the public as a whole. Additionally, the benefits of RBC transfusions are transient, requiring some patients to receive multiple transfusions during the duration of their chemotherapy treatment.
- Although the blood supply is currently considered safer than in the past, there are both known and unknown risks associated with transfusions.
- Blood transfusions also can be associated with transfusion reactions or other antibody mediated problems.
- Physicians have stated that transfusions are disruptive for patients, caregivers and physicians and divert substantial resources that would otherwise be available for patient care.
Proposed Risk Management Program to Preserve Access and Minimize Risks
Additional risk management, through additional product labeling updates and a formal education and communication program, will minimize risk while the necessary data are acquired from clinical trials designed to address the unanswered safety questions. Amgen will propose to the ODAC a risk program that is designed to minimize the risks of ESA therapy, discourage off-label use, and promote educated benefit-risk decisions for each patient.
Aranesp(R) (darbepoetin alfa) was approved by the FDA in September 2001 for the treatment of anemia associated with chronic renal failure (CRF), for patients on dialysis and patients not on dialysis. In July 2002, the FDA approved weekly dosing of Aranesp for the treatment of anemia caused by concomitantly administered chemotherapy in patients with nonmyeloid malignancies and in March 2006, the FDA approved every-three-week dosing in these patients.
Amgen launched EPOGEN(R) (Epoetin alfa), one of the first biologically derived human therapeutics, into the U.S. medical marketplace in 1989 for the treatment of anemia in patients with chronic renal failure on dialysis. EPOGEN is a recombinant protein with the same mechanism of action as endogenous human erythropoietin, a protein produced by the kidneys to stimulate the production of oxygen-transporting red blood cells.
Important Aranesp and EPOGEN Safety Information
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.
- ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of greater than or equal to 12 g/dL.
- The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of less than 12 g/dL.
- To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions.
- Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
- Discontinue following the completion of a chemotherapy course.
Perisurgery: EPOGEN(R) increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
Aranesp and EPOGEN are contraindicated in patients with uncontrolled hypertension.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
Forward Looking Statement
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