Palifermin

Mucositis, an inflammation of the oral and gastrointestinal mucosa, is often induced in patients receiving high-dose chemotherapy and radiotherapy for hematological malignancies. Patients with head and neck cancer, as well as, patients receiving stem cell transplants are particularly at risk for developing this debilitating side effect that can lead to swallowing difficulty, thereby, necessitating total parenteral nutrition in severe cases. Other complications include potential infections, overuse of opioid analgesics to treat the pain, and extended hospitalization. Palifermin, a recombinant human keratinocyte growth factor (KGF), has been approved as a novel agent to treat this condition. As a member of the heparin-family of fibroblast growth factors, palifermin provides protection from the damaging effects of chemotherapy and radiation by selectively promoting epithelial cell proliferation, leading to an increased rate of healing. Palifermin is produced by recombinant DNA technology utilizing an expression vector encoding KGF_des-23. As an N-terminal, truncated version of endogenous KGF having amino acids 1–23 deleted, palifermin has greater stability while retaining biological activity.Serious adverse events were similar to those observed with placebo and were typically attributed to the underlying malignant disease. Minor side effects were skin rash (＜1%), dysesthesia, pruritis, tongue thickening, and transient taste changes. While keratinocyte growth-factor receptor is not expressed in hematological cancers, it is possible that secondary tumors that express this receptor could be advanced by palifermin treatment. Long-term evaluation of this risk is ongoing; however, at 12 months, the progression-free survival rates were similar for palifermin and placebo. The recommended dosage of palifermin is 60 Mg/kg/day, delivered by i.v. bolus injection, for 3 consecutive days before and three consecutive days following myelotoxic therapy, insuring that the third dose is delivered greater than 24 h before the commencement of the myelotoxic therapy. No formal drug–drug interaction studies have been conducted with palifermin. .

Amgen (US)

Kepivance