Mucositis :: Palifermin – Kepivance – to treat mucositis with cancer treatments

The Food and Drug Administration (FDA) approved a new intravenous biologic product, palifermin (trade-name Kepivance) to help reduce the chance that certain cancer patients, those with blood cancers undergoing chemotherapy and radiation in preparation for bone marrow transplants, will develop mucositis. Palifermin also shortens the duration of the condition.

Mucositis (painful sores and ulcers in the lining of the mouth) is a common complication of the high-dose chemotherapy and radiation therapy regimens associated with bone marrow transplant. Patients suffering from mucositis have difficulty eating and swallowing. In the most severe form of the condition, patients cannot eat or drink at all and must receive nutrition and fluid replacement through their veins.

Palifermin is a man-made version of a naturally occurring human protein called keratinocyte growth factor (KGF). KGF stimulates the growth of cells in the skin and on the surface layer of the mouth, stomach and colon. Palifermin, like the natural KGF, also stimulates cells on the surface layer of the mouth to grow. This is thought to lead to faster replacement of these cells when killed by the cancer treatments and is believed to speed up the healing process of mouth ulcers.

In a study of 212 patients with leukemia or lymphoma who were receiving high doses of chemotherapy and radiation treatments associated with bone marrow transplantation, 98% of the patients who did not receive palifermin developed severe mucositis compared to 63% of those who received the drug. Also, for those who received the drug, severe mucositis lasted an average of three days, compared to nine days for those receiving a placebo.

Palifermin was given intravenously for three days before cancer treatment began and three days following the treatment.

The most common side effects of palifermin were skin rash, unusual sensations in the mouth, such as tingling, and increases in blood proteins suggesting pancreatic irritation. No serious side effects have been reported related to use of palifermin. Palifermin has not yet been shown to be safe and effective in patients being treated for forms of cancer other than leukemia or lymphoma.

Palifermin will be marketed with the trade-name Kepivance and is manufactured by Amgen Inc., Thousand Oaks, Calif.