Fda Approves Ovarian Cancer Drug

A drug derived from the bark of a Chinese tree was approved by the Food and Drug Administration Wednesday to help women whose ovarian cancer has progressed despite other treatments.

Topotecan is the first of a new class of cancer drugs that inhibit an enzyme essential for the growth of tumors. It appears to work at least as well as the widely used ovarian cancer therapy Taxol.

While doctors caution that it’s not a breakthrough, FDA Commissioner David Kessler said topotecan “is an important option” for advanced patients.

Manufactured by SmithKline Beecham Pharmaceuticals, topotecan will be sold under the name Hycamtin and will begin sales in several weeks.

In a study of 337 women, topotecan helped shrink the tumors of 17 percent of patients, a response rate comparable to that experienced by patients taking Taxol, the FDA said.

The study found no statistically significant difference in survival between patients taking topotecan and those taking Taxol.

And topotecan patients experienced somewhat more severe side effects, particularly a drop in their immune system’s ability to fight infections. This side effect is treatable, although some women may require hospitalization.