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PLEASE NOTE - A full version of the ODAC press release and an Ovarian
Cancer Backgrounder is available FREE by e-mailing ovarian at mcny.com. In
the subject area please write - subscribe ovarian "your e-mail address."
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SmithKline Beecham's Hycamtin for Recurrent Ovarian Cancer
Recommended for Approval by FDA Committee
BETHESDA, Md., April 19, 1996 -- The Oncologic Drugs Advisory
Committee of the Food and Drug Administration today unanimously
recommended approval of Hycamtin (topotecan hydrochloride) from
SmithKline Beecham for the treatment of patients with metastatic ovarian
cancer after failure of initial or subsequent chemotherapy. The
favorable recommendation was based on a review of data from two large,
international, multicenter trials conducted on patients with recurrent
ovarian cancer. In an open, randomized comparative study, patients
treated with Hycamtin demonstrated a statistically significantly longer
progression-free survival (time to progression) and a numerically
superior response rate than patients treated with paclitaxel (Taxol).
Hycamtin is the first topoisomerase I inhibitor to be recommended
for approval in the U.S. This new class of drugs kills cancer cells by
inhibiting the enzyme topoisomerase I, which is essential in the
replication of DNA in human cells. Hycamtin offers oncologists another
tool to fight this deadly disease, which is the leading cause of
gynecologic cancer deaths among American women and will kill an estimated
14,800 women annually.
As with many cancer chemotherapeutic agents, the main side effect
demonstrated by Hycamtin in clinical trials was suppression of blood
cells produced in the bone marrow that was predictable, noncumulative,
reversible and manageable. The most frequently reported non-hematologic
side effects were gastrointestinal, including nausea and vomiting.
However, only eight percent of all patients experienced nausea that
prevented them from eating or drinking significant amounts.
A worldwide leader in healthcare, SmithKline Beecham has made a
commitment to discover, develop and market pharmaceutical products that
provide greater hope and improved clinical care to people who suffer from
the many diseases collectively known as cancer.
For information on cancer education or cancer patient support, please
call the CancerCare Counseling Line at 1-800-813-HOPE.
For further information on Hycamtin please see the instructions below.
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PLEASE NOTE - A full version of the ODAC press release and an Ovarian
Cancer Backgrounder is available FREE by e-mailing ovarian at mcny.com. In
the subject area please write - subscribe ovarian "your e-mail address."
The information will automatically be sent to you. To delete your name
please write unsubscribe ovarian "your e-mail address."
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