More ESA labeling changes
The FDA has approved updated safety information for erythropoiesis-stimulating agents (ESAs), including Aranesp (darbepoetin alfa, from Amgen), Epogen (epoetin alfa, from Amgen), and Procrit (epoetin alfa, from Ortho Biotech).
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 ≥12g/dL. The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of <12g/dL.
Modifications to the labeling reflect the unplanned interim analysis of the PREPARE study in neo-adjuvant breast cancer which targeted hemoglobin levels of 12.5-13g/dL and from the GOG-191 study in cervical cancer which targeted levels of 12-14g/dL.