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Safety labeling updated for ESAs
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On Friday, the FDA approved updated safety information for erythropoiesis-stimulating agents, including a boxed warning in the labeling for increased mortality, serious cardiovascular and thromboembolic events and tumor progression.
Darbepoetin alfa (Aranesp, Amgen) and epoetin alfa (Procrit, Johnson & Johnson) are included in the safety update, according to a March 7 press release.
Follow-up data from the Gynecologic Oncology Group's cervical cancer study, as well as interim results from the neo-adjuvant breast cancer study, Preoperative Epirubicin Paclitaxel Aranesp (PREPARE), were added to the labeling.
Clinical studies have shown that ESAs shortened overall survival and time-to-tumor progression in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers, when dosed to target hemoglobin ≥12 g/dL. Patients also experienced greater risks for death and cardiovascular events, according to an Amgen press release.
Last month, a meta-analysis revealed an increased risk for venous thromboembolism and mortality in patients with anemia of cancer who received ESAs.
Amgen will discuss this new data, along with the safety and science of ESAs in oncology, at the Oncologic Drugs Advisory Committee meeting this Thursday, March 13, 2008. Visit HemOncToday.com for coverage of the ODAC meeting later this week.
Amgen is currently working with the FDA to address safety concerns surrounding ESAs, notify patients of the risk:benefit ratio of ESAs and inform the public and oncology community of updates on ESAs. Together with Ortho Biotech, Amgen is scheduled to address the prescribing revisions in a letter to healthcare professionals that will be posted on the company's Web site. – by Stacey L. Adams