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.