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www.fdanews.com/articles/84884-gsk-s-hycamtin-snda-gets-priority-review

GSK'S HYCAMTIN SNDA GETS PRIORITY REVIEW

February 27, 2006

The FDA has placed a priority review on GlaxoSmithKline's (GSK) supplemental new drug application (sNDA) for an expanded use of its cancer drug Hycamtin.

The sNDA seeks marketing approval of Hycamtin (topotecan HCl) in combination with cisplatin for the treatment of advanced cervical cancer in patients who were not cured by surgery or radiation therapies, GSK said recently.

The application is based on results of a Phase III trial that demonstrated a survival advantage with the use of Hycamtin in combination with cisplatin compared to cisplatin alone. Hycamtin currently is indicated in certain cases for the treatment of ovarian cancer and small-cell lung cancer.