Amgen's Kepivance approved by FDA for severe oral mucositis in cancer patients.
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 www.amgentrials.com.
Contact: Trish Hawkins - (805) 447-4587, Web site: www.amgen.com
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|Article Type:||Brief Article|
|Date:||Jan 31, 2005|
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