US biotechnology major Amgen has been granted regulatory approval in the European Union for Kepivance (palifermin), a first-in-class compound for the treatment of oral mucositis, or mouth sores, in cancer patients.
Palifermin, a recombinant form of keratinocyte growth factor, was first approved in the USA for this indication last December, and is also registered in Australia, and under review in Canada and Switzerland. The drug is approved for use in cancer patients with haematological cancers who require an autologous blood and bone marrow transplant. In the EU, approximately 13,000 cancer patients undergo this type of procedure each year.
Willard Dere, Amgen's chief medical officer, said Kepivance is the first and only product available in this market that will "help physicians to protect patients from the devastating consequences of oral mucositis."
The European Medicine Agency (EMEA)'s decision is based on a pivotal Phase III double-blind study which found that Kepivance reduced the incidence of grade 4 oral mucositis to 20% from 62% in the placebo arm. The overall incidence of grade 3-4 mucositis - a condition so severe that patients can barely swallow liquids - was reduced to 63% from 98%.
Amgen is also carrying out trials with the aim of expanding the use of the drug to include patients receiving aggressive chemotherapy for head and neck and lung cancers.
A Datamonitor report, published in January suggests that Kepivance has sales potential of around $200 million dollars in its current indication, but could expand to more than $1 billion if approval comes in additional uses, particularly solid tumours.