Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has invited the Company to participate at an upcoming meeting of the Oncologic Drugs Advisory Committee (ODAC).
The Company?s understanding is that the ODAC will review progress made by Amgen and other sponsors in delineating the effects of erythropoiesis-stimulating agents (ESAs) on survival and tumor progression in cancer patients. The ODAC meeting is scheduled for May 10, 2007.
?We look forward to providing an update to the ODAC on the Aranesp? (darbepoetin alfa) 103 trial involving cancer patients with anemia not due to chemotherapy. We have recently posted a detailed synopsis of the study results on public Web sites, including clinicalstudyresults.org and clinicaltrials.gov,? said Roger M. Perlmutter, M.D., Ph.D., executive vice president of research and development for Amgen.
?The upcoming ODAC meeting will also provide a forum for the review of our ongoing Aranesp pharmacovigilance program,? Dr. Perlmutter continued, ?which we undertook following the May 2004 ODAC meeting, including a review of data then available from the Aranesp 145 trial involving patients with previously untreated small cell lung cancer.? Dr. Perlmutter noted that the Aranesp 145 trial has reached its pre-specified number of events. Amgen is now collecting data from the trial and expects to announce topline results from this study in May.
Additionally, Amgen is in discussions with the FDA with the goal of updating patient safety information on all ESA labels that will take the form of a boxed warning and will apply to both nephrology and oncology indications for the class of approved ESAs. While Amgen?s interactions with the FDA are ongoing and exact language for the updated prescribing information is not final, the company is committed to providing timely and appropriate communications to patients and physicians. When the updated prescribing information is final, Amgen will inform healthcare professionals about the revisions to the U.S. prescribing information through a ?Dear Healthcare Professional? letter and will post the letter and updated prescribing information on Amgen?s web site, www.amgen.com.
Amgen?s top priority is patient safety. Aranesp is indicated for the treatment of chemotherapy-induced anemia and anemia associated with chronic kidney disease (CKD), for patients on dialysis and patients not on dialysis. EPOGEN? (Epoetin alfa) is indicated for the treatment of anemia associated with CKD, for patients on dialysis. The dosing instructions recommend targeting hemoglobin levels not to exceed 12 g/dL. Amgen always recommends that physicians and other prescribers carefully follow FDA-approved prescribing instructions.