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From A HSBC research report 15/12/05 on Amgen

Kepivance (palifermin) is a recombinant form of human keratinocyte growth factor that was approved by the FDA in December 2004 for treatment to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving high-dose chemotherapy following stem cell transplant.
Kepivance also received a favorable opinion from the European Medicines Agency (EMEA) and is awaiting final approval in Europe.
In a 212-patient Phase III trial, Kepivance reduced the incidence of grade 4 oral mucositis to 20%, versus 62% in patients treated with placebo. The
market for oral mucositis for patients who receive a stem cell transplant is only about 11,000 patients per year.
With its current label, we estimate Kepivance has peak sales potential of USD200-300m annually.
However, we believe Kepivance will demonstrate efficacy in treating oral mucositis in patients receiving myelosuppressive therapy(chemotherapy/radiation) across all solid-tumor indications where the incidence of oral mucositis is approximately 400,000.
Amgen is exploring dosing of the drug to optimize the efficacy and is conducting a Phase III trial in head-and-neck cancer, where oral
mucositis occurs frequently and severely. We expect an update from that trial at the 2006 ASCO meeting. If this is successful, we expect the label
for Kepivance to be expanded in 2008 to include treatment of oral mucositis in patients receiving myelosuppressive treatment for head-and-neck
cancer, which will likely lead to significant offlabel use in other solid tumors.