FDA Approves First Drug Treatment for Late-Stage Cervical Cancer
Topotecan hydrochloride (Hycamtin) was approved by the Food and Drug Administration (FDA) for use in combination with cisplatin for Stage IVB, recurrent, or persistent cancer of the cervix. This chemotherapy treatment improved survival in clinical trials by about 50 percent over cisplatin alone, from 6.5 to 9.4 months, and "is a potentially life-prolonging option for thousands of women," said Acting FDA Commissioner Dr. Andrew von Eschenbach.
The drug's side effects are serious, however, including a drop in white blood cells and platelets. The approval also stipulates that a patient's physician must determine that surgery or radiation therapy is not likely to be effective. Produced by GlaxoSmithKline, the drug is already approved for ovarian and small-cell lung cancers.