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Approval of Drugs for the Treatment of Late-Stage Cancer

The U.S. Food and Drug Administration have approved a combination of Hycamtin (chemical name, topotecan hydrochloride) and cisplatin to be //used as the first drug treatment for women with late-stage cancer of the cervix at which stage surgery or radiation therapy are often ineffective. The agency has also approved Gardasil as the first vaccine developed to prevent cervical cancer. Hycamtin had been earlier approved in 1996 for treating ovarian cancer and in 1998 for small cell lung cancer.

Cervical cancer mostly occurs in women over the age of 40. there. Over 10,000 new cases of cervical cancer and 3,700 related deaths are reported each year in the United States.

‘We are making great strides in the fight against cervical cancer, a disease that, world wide, is the second most common cancer in women,’ said Dr. Andrew von Eschenbach, Acting FDA Commissioner. ‘This course of drug therapy is a potentially life-prolonging option for thousands of women.’

Women with recurrent, incurable (stage IVB) or persistent cancer of the cervix are recommended this combination of Hycamtin and cisplatin. Cancer in this stage often spreads to other organs and is unlikely to respond to treatment with surgery or radiation.

293 patients took part in clinical trials with Hycamtin plus cisplatin and cisplatin alone. While most of the participants had undergone prior radiation therapy some had also undergone prior surgery. The combination therapy has extended life to about three months longer than patients on cisplatin alone.

However the downside to Hycamtin is that its use is associated with a significant risk of neutropenia , thrombocytopenia, nausea, anemia and vomiting. These incidences were significantly higher among patients receiving the combination treatment rather than those receiving cisplatin alone.

Hycamtin is manufactured by GlaxoSmithKline, Research Triangle Park, NC.

Gardasil has been approved as t
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