Women's Health Weekly
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Cervical Cancer
U.S. FDA accepts sNDA for Hycamtin with Cisplatin for the treatment of advanced cervical cancer
March 16th, 2006
GlaxoSmithKline (GSK) announced that the supplemental new drug application (sNDA) submitted to the U.S. Food & Drug Administration (FDA) on December 15, 2005 for Hycamtin (topotecan HCl) for Injection, has been accepted. The FDA has also agreed to a priority review. The sNDA seeks marketing approval for the new use of Hycamtin in combination with cisplatin, for the treatment of Stage IVB recurrent or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. The application is based on results from a randomized, multicenter phase III trial, designed and conducted by the Gynecologic Oncology Group...
Source: Women's Health Weekly (2006-03-16)
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