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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P06-81
June 15, 2006

Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


 

FDA Approves First Drug Treatment for Late-Stage Cervical Cancer

The U.S. Food and Drug Administration has approved a combination of Hycamtin (topotecan hydrochloride) and cisplatin for use as the first drug treatment for women with late-stage cancer of the cervix when a physician determines that surgery or radiation therapy are unlikely to be effective. The approval includes a new indication for Hycamtin, which was approved in 1996 for treating ovarian cancer and in 1998 for small cell lung cancer.

In the United States there are an estimated 10,000 new cases of cervical cancer and about 3,700 related deaths each year.

"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."

The combination of Hycamtin and cisplatin is specifically indicated for women with Stage IVB (incurable), recurrent, or persistent cancer of the cervix which spreads to other organs and is not likely respond to treatment with surgery or radiation.

In clinical trials involving this patient population, 293 patients were randomized to Hycamtin plus cisplatin or to cisplatin alone. Most of the participants had received prior radiation therapy as the standard treatment, while some may have undergone prior surgery. The combination therapy significantly improved survival compared to the use of cisplatin alone. Patients on combined therapy survived (9.4 months), about three months longer than patients on cisplatin alone (6.5 months).

Hycamtin is associated with a significant risk of neutropenia (a drop in white blood cell count), a condition which makes it more difficult for the body to fight infections. Serious side effects also include thrombocytopenia, a decrease in blood platelets that can lead to excessive bleeding and anemia. Less serious side effects include nausea and vomiting. The incidences of neutropenia, anemia, and thrombocytopenia were significantly increased among patients receiving the combination treatment compared to those receiving cisplatin alone, as were nausea and vomiting, mucositis, rash, and liver toxicity.

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

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