Johnson and Johnson reaffirms safety and efficacy of ESAs

Johnson & Johnson (J&J) has highlighted that the totality of scientific data reaffirms the safety and efficacy of erythropoiesis-stimulating agents (ESAs) to treat chemotherapy-induced anaemia.

Craig Tendler, vice-president of medical affairs at the J&J subsidiary Ortho Biotech, confirmed: “ESA use within the label has not been associated with increased risk of mortality or disease progression.”

His comments arrive ahead of a meeting of the Oncologic Drugs Advisory Committee Meeting (ODAC) to review the use of Ortho Biotech’s candidate Procrit (Epoetin Alfa).

The pharmaceutical firm has now submitted all available data to the US Food and Drug Administration (FDA) in preparation for the meeting.

Ortho Biotech will present the data and suggest that vascular thrombotic events are the most plausible explanation for increased mortality with ESAs in cancer patients seen in some studies with high haemoglobin targets.

Dr Tendler said that the firm continued to support healthcare professionals in recommending the lowest dose of ESA that will gradually increase the haemoglobin concentration to a level that will avoid the need for blood transfusion.

Earlier this month Ortho Biotech modified prescribing information for Procrit following guidance from the FDA.