Is Kepivance® (palifermin) effective in reducing the incidence and duration of severe oral mucositis (Grade 3/4)?
Kepivance® is effective in reducing the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring HSCT. In clinical studies, Kepivance® significantly reduced the incidence of severe oral mucositis (63% vs 98% for placebo; P < 0.001). Kepivance® also significantly reduced the median duration of severe oral mucositis by 6 days among all patients studied (3 vs 9 days for placebo; P < 0.001). In the subset of patients who developed severe oral mucositis, Kepivance® patients experienced 3 fewer days of severe oral mucositis (6 vs 9 days for placebo; P < 0.001) and 4 fewer days of the most severe oral mucositis (Grade 4) (2 vs 6 days for placebo; P = 0.004).