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FDA Announces Approval Of GSK Drug Hycamtin To Treat Cervical Cancer
FDA on Thursday announced the approval of GlaxoSmithKline's drug Hycamtin for use in combination with cisplatin-based chemotherapy to treat late-stage cervical cancer, the AP/Washington Post reports. Hycamtin is the first drug to be approved to treat persistent, incurable or recurrent cervical cancer in women for whom radiation therapy and surgery are unlikely to be successful. The drug in 1996 was approved to treat ovarian cancer and in 1998 was approved to treat small-cell lung cancer (AP/Washington Post, 6/15). According to FDA, the approval is based on clinical trials of 293 women who received either Hycamtin and cisplatin-based chemotherapy or cisplatin alone, Reuters reports. The study finds that women receiving the combination drug treatment lived an average of 9.4 months, while those taking just cisplatin lived an average of 6.5 months. "This course of drug therapy is a potentially life-prolonging option for thousands of women," acting FDA Commissioner Andrew von Eschenbach said in a statement (Heavey, Reuters, 6/15). Hycamtin -- which is administered by infusion -- works by damaging the genetic material contained in cancer cells, destroying them as they divide, the AP/Post reports. However, the drug treatment also can lower white blood cell counts that are important in fighting infections (AP/Washington Post, 6/15). Other side effects of Hycamtin include nausea, vomiting, diarrhea, hair loss and a decrease in blood platelets -- which can lead to excessive bleeding and anemia (Reuters, 6/15). About 10,000 cases of cervical cancer are detected annually in the U.S., and about 3,700 women die of the disease annually (AP/Washington Post, 6/15).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
View drug information on Hycamtin.
FDA Announces Aprobarea GSK Drug Hycamtin pentru tratarea cancerului de col uterin - FDA Announces Approval Of GSK Drug Hycamtin To Treat Cervical Cancer - articole medicale engleza - startsanatate
