Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Kepivance (Amgen)
vials containing 6.25 mg as lyophilised powder for reconstitution
Approved indication: oral mucositis
Australian Medicines Handbook section 14.5.2

Many patients who are treated with high doses of chemotherapy or radiation, particularly for head and neck cancers, develop oral mucositis. This can be very painful and in severe cases the patient may be unable to swallow. Mucositis increases the risk of the patient developing serious infections.

If mucositis is the result of damage to the oral tissues, then it could be ameliorated by giving growth factors. Palifermin is a genetically engineered form of keratinocyte growth factor which stimulates the development of epithelial cells.

The efficacy of palifermin has been assessed in 212 patients having chemotherapy and radiation before stem cell transplantation for haematological malignancies. These patients were given a daily intravenous injection of palifermin or placebo for three days before their treatment. They received three more doses following transplantation. Significant mucositis developed in 98% of the placebo group, but only in 63% of the patients given palifermin. It lasted six days with palifermin, but nine days with placebo. This probably contributed to the reduced use of opioid analgesics with palifermin. Although 75% of the patients given palifermin developed febrile neutropenia, this was significantly less than the 92% in the placebo group.1

Adverse effects which occur more frequently in patients given palifermin include rash, itching, erythema and altered taste and other sensations in the mouth. Patients may also complain of arthralgia, paraesthesia, oedema and cough. There is a theoretical risk that palifermin could promote cataract formation.

Animal studies suggest that palifermin can enhance the growth of epithelial tumours. As safety and efficacy have not been shown in other tumours, palifermin is currently only approved for patients with haematological malignancies receiving myelotoxic therapy requiring stem cell support.

manufacturer declined to supply data

The Transparency Score ( ) is explained in New drugs: transparency', Vol 37 No 1, Aust Prescr 2014;37:27.