The approval is based on a pivotal phase III double-blind study that compared Kepivance with placebo in the development of oral mucositis in patients with hematologic malignancies.
In the study the incidence of the most debilitating grade of oral mucositis (grade 4) was three times less with Kepivance (20% versus 62% with placebo), and the incidence of grade 3-4 mucositis where patients can only swallow liquids, if anything, was reduced by approximately one-third (63% versus 98% with placebo). The drug also reduced the duration of painful oral mucositis (grades 2-4) by almost half or approximately one week (8 days versus 14 days with placebo).
“Now, physicians in the EU have an option to decrease the incidence, duration and severity of oral mucositis, rather than only trying to control the pain and discomfort caused by it,” said Dr Dietger Niederwieser, elected president of the European Group for Bone and Marrow Transplantation (EBMT). “With palifermin, we can help protect patients undergoing blood and bone marrow transplant from this extremely painful side effect that can impact their ability to eat, drink and swallow.”
In the EU, approximately 13,000 cancer patients undergo autologous blood and bone marrow transplant each year.