Ortho Biotech, a subsidiary of Johnson & Johnson, issued statements regarding FDA Advisory committee's recommendations to restrict access to erythropoiesis-stimulating agents (ESAs) for chemotherapy-induced anaemia, (CIA), in patients with metastatic breast and head and neck cancer, and patients treated with curative intent. The fully informed patients and their physicians should have the choice to use this important medication, which is the only therapeutic alternative to blood transfusion, said the company.
"Over the past several months, the company provided the FDA with substantial new data that give important insight into the safety of ESAs," said Jay Siegel, M.D., group president, research and development. "We hope that the FDA will now take time to review this substantial body of data before reaching its final decision."
The FDA has not yet reviewed new or follow-up survival data accounting for approximately 50 percent of the 7,444 patients in the company's database. The totality of available data support continuing the option to use ESAs according to the label in patients with chemotherapy-induced anaemia (CIA).
Out of a total of 59 controlled studies with survival data, the FDA has focused on eight studies of concern. All eight studies researched investigational uses of the drug, and the Procrit (Epoetin alfa) label contains specific warnings against such uses.
In addition, a representative of the Cochrane Collaboration who attended the meeting confirmed that the group is about to generate important new analyses regarding the safety of ESA use in CIA. The FDA should consider these analyses before making its final decision.
The current product labelling prominently reflects all known risks of ESAs, including thrombovascular events (TVEs). TVEs are a plausible explanation for increased mortality observed in studies with high haemoglobin (Hb) targets. When ESA use is targeted to Hb higher than 12 grams per deciliter of blood (g/dL), the risk is unacceptably increased.
Ortho Biotech will continue to evaluate and minimize risk of ESAs within the labelled treatment setting. We remain committed to continuing to educate healthcare professionals and patients regarding the appropriate use of Procrit.
Procrit is used for the treatment of anaemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anaemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.