US FDA orders ESA labelling changes to narrow use

The US FDAhas ordered labelling changes for erythropoiesis-stimulating agents (ESAs) to advise against use in patients receiving chemotherapy in the adjuvant setting and place a haemoglobin level ceiling for initiation of treatment. However, the FDA opted not to restrict use of the anaemia treatments in patients according to tumour types, despite a recommendation to the contrary by its oncologic drugs advisory panel.

Although the decision not to restrict use based on tumour type is a huge win for Amgen, the company is nevertheless likely facing the loss of a big chunk of sales as a result of the labelling changes on adjuvant use and dosage and administration