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Date: Wednesay, May 29, 1996 FOR IMMEDIATE RELEASE Contact: Susan M. Cruzan (301)443-3285
The Food and Drug Administration approved the first member of a promising new class of anti-tumor drugs for use in patients whose ovarian cancer has progressed after the failure of first-line chemotherapy.
FDA's approval of Hycamtin (topotecan), the first in the world for the drug, was granted in a little over five months after FDA received the submission.
"This approval reflects the spirit of the administration's new initiative on cancer drugs, which President Clinton announced in March," said HHS Secretary Donna E. Shalala. "We are determined to make cancer medicines available faster and more widely to patients who need them."
FDA Commissioner David A. Kessler, M.D., said, "Ovarian cancer that has relapsed can be very difficult to treat. This drug is an important option for these ovarian cancer patients whose disease is not responding to other therapies."
Topotecan is a member of the new class of drugs called camptothecins, which work by inhibiting an enzyme called topoisomerase-I. Early studies that revealed the possible
effectiveness of these drugs in cancer treatment were sponsored by the Natural Products Program of the National Cancer Institute.
Topotecan has been proven useful in treating patients with ovarian cancer whose cancer has recurred following treatment with first-line therapies that include platinum-containing drugs. Two multi-center clinical trials found that topotecan reduced tumor size in 17 percent of 337 patients with ovarian cancer for an average of about five months, a response at least as good as that seen in patients treated with Taxol (paclitaxel), another ovarian cancer drug, in one of the studies.
Topotecan is associated with a significant risk of neutropenia (a temporary drop in white blood cell counts), making it more difficult to fight infections. As a result, some patients may require hospitalization and antibiotic treatment. Other side effects include thrombocytopenia, a decrease in blood platelets that can lead to excessive bleeding; and anemia. Less serious side effects include gastrointestinal effects such as nausea and vomiting.
On April 19 of this year, FDA's Oncologic Drugs Advisory Committee unanimously recommended approval of topotecan as second line therapy to treat advanced ovarian cancer. Topotecan will be marketed by SmithKline Beecham of Philadelphia, Pa.