FDAnews
www.fdanews.com/articles/87641-gsk-s-hycamtin-gets-approval-as-part-of-cervical-cancer-combination-treatment

GSK'S HYCAMTIN GETS APPROVAL AS PART OF CERVICAL CANCER COMBINATION TREATMENT

June 16, 2006

The FDA has approved GlaxoSmithKline's (GSK) Hycamtin (topotecan HCl), in combination with cisplatin, for the treatment of Stage IV-B, recurrent or persistent carcinoma of the cervix, which is not treatable by surgery or radiation therapy. The expanded indication is based on Phase III results that demonstrated a survival advantage by using Hycamtin in combination with cisplatin compared with cisplatin alone.

Hycamtin belongs to a class of drugs known as the topoisomerase I (topo-I) inhibitors. Topo-I is a naturally produced protein essential for cell division in both normal and cancer cells. Interaction between topo-I and Hycamtin results in permanent damage to the cell's genetic material and the death of dividing cancer cells. Hycamtin was originally approved for the treatment of small-cell lung cancer sensitive disease after failure of first-line chemotherapy and for the treatment of metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.