June 15, 2006 -- The FDA has approved the first drug treatment ever for women with late-stage.
The combination treatment may extend patient's lives, according to the FDA.
Each year, there are an estimated 10,000 new cases of cervicalin the U.S. and about 3,700 women die from the disease, according to the FDA.
"We are making great strides in the fight against cervical cancer, a disease that, worldwide, is the second most common cancer in women," says acting FDA commissioner Andrew von Eschenbach, MD, in an FDA news release. "This course of drug therapy is a potentially life-prolonging option for thousands of women," he continues.
Drug Treatment, Survival
Hycamtin's use with cisplatin in late-stage cervical cancer is a new indication for Hycamtin.
The FDA first approved the drug in 1996 for. In 1998, the FDA added treatment of small cell to Hycamtin's approved uses.
With the new FDA ruling, the combination of Hycamtin and cisplatin is specifically indicated for women with stage IVB (incurable), recurrent, or persistent cancer of the cervix, which has spread to other organs and is not likely respond to treatment with surgery or radiation.
In clinical trials involving women with stage IVB cervical cancer, 293 patients were randomly assigned to receive Hycamtin plus cisplatin or cisplatin alone. Most participants had already received radiation therapy as standard treatment, while some may have undergone prior surgery.
Survival was better for those on the combination treatment (9.4 months) compared with cisplatin alone (6.5 months), a difference of about three months, states an FDA news release.
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 .
Less serious side effects include nausea and vomiting.
The incidences of neutropenia, anemia, and thrombocytopenia were significantly higher among patients receiving the combination treatment compared with those receiving cisplatin alone, as were nausea and vomiting, mucositis ( or sores in the GI tract), rash, and liver toxicity, the FDA reports. The word "significantly," in scientific studies, means something is not likely simply due to chance.
Hycamtin is made by GlaxoSmithKline, a WebMD sponsor.