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Amgen's Kepivance approved by FDA for severe oral mucositis in cancer patients.

Amgen, Inc., Thousand Oaks, CA, announced the US Food and Drug Administration (FDA) has approved Kepivance (palifermin), the first and only therapy to decrease the incidence and duration of severe oral mucositis (mouth sores) in patients with hematologic cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant. The company cautions that the safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies.

In patients with oral mucositis, the cells lining the mouth and throat are damaged by the chemotherapy drugs and/or radiation used in cancer treatment. Oral mucositis can be extremely painful and can have a devastating impact on patients, who often require longer hospitalization, higher doses of morphine, and intravenous feeding to receive nutrition and maintain hydration.

Results of a pivotal Phase III study published in the December 15 New England Journal of Medicine reported that the incidence of the most debilitating grade of mucositis (grade 4) was 3 times less with Kepivance (20% vs. 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% vs. 98% with placebo), Amgen said in the press release. Kepivance also reduced the duration of painful oral mucositis (grades 2-4) by almost half or approximately one week (8 days vs. 14 days with placebo).

More information about the ongoing Kepivance clinical trials is available online at

Contact: Trish Hawkins - (805) 447-4587, Web site:
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Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Jan 31, 2005
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