ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Thursday, May 30, 1996 TAG: 9605300083
SECTION: NATIONAL/INTERNATIONAL PAGE: A-8 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Associated Press
A drug derived from the bark of a Chinese tree was approved by the Food and Drug Administration on 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.
Manufactured by SmithKline Beecham Pharmaceuticals, topotecan will be sold under the name Hycamtin. Sales will begin in several weeks.
Ovarian cancer strikes about 26,700 American women every year, killing about 14,800.
In a study of 337 women, topotecan helped shrink the tumors of 17 percent, 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.
SmithKline touted data that suggested topotecan stopped ovarian tumors from progressing for 23 weeks, compared with 14 weeks for Taxol patients.
However, topotecan patients experienced 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.
``I don't think we can say with certainty yet whether it's better than Taxol,'' cautioned FDA oncology director Dr. Robert DeLap. ``We simply don't have enough data to address the question... And they may turn out to be complementary drugs, so the question of better may not be an issue.''
Whenever a new class of medicines is discovered, one hope is that combining it with older drugs could deal tumors a one-two punch. Topotecan inhibits an enzyme called topoisomerase-I that is important for tumor growth. Existing drugs have fought some cancers by attacking a related enzyme, topoisomerase-II. The National Cancer Institute and SmithKline are studying whether combining the two types of drugs could help some patients.
LENGTH: Short : 45 linesby CNB