The updated boxed warning states that 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.
In the "Increased Mortality and/or Tumor Progression" warning section of the updated labeling, the interim results of the Preoperative Epirubicin Paclitaxel Aranesp (PREPARE) study in neo-adjuvant breast cancer were added as well as follow up data from the Gynecologic Oncology Group study in cervical cancer.
Amgen and Johnson & Johnson have submitted all available clinical data to the FDA including the data from these two study studies now reflected in the product labeling, as well as data from other informative controlled clinical studies with ESAs in the oncology setting. In general, these results have not changed the benefit-risk profile significantly of ESAs in this setting from previously available data discussed at the May 4, 2004, and May 10, 2007, Oncologic Drugs Advisory Committee (ODAC) meetings. Amgen will address the science and safety of ESAs in oncology, including these new data, at an upcoming ODAC meeting next week on Thursday, March 13, 2008.
Amgen is informing healthcare professionals about the revisions to the U.S. prescribing information through a joint "Dear Healthcare Professional" letter with Ortho Biotech and will post the letter along with the updated prescribing information on Amgen's Web site, www.amgen.com.
"Amgen is committed to ensuring physicians and patients have the latest information about ESAs in order to make appropriate treatment decisions," said Sean Harper, Amgen's Chief Medical Officer. "Last year, we communicated the new safety information in several ways, including disseminating DHCP letters, posting the new labeling on our Web site, focusing promotional activity from March until the May ODAC on warnings and safety data, and hosting ongoing briefings with the oncology community."
Amgen's ongoing risk management activities includes working with the FDA to design additional pharmacovigilance studies to address safety concerns around ESAs, developing a patient medication guide to communicate the benefit/risk of ESAs, and continuing to publicly communicate updates on ESAs to the public and oncology community.
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