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| |  Hycamtin for Recurrent Ovarian Cancer Cleared for Marketing by FDA PHILADELPHIA, May 29, 1996 -- SmithKline Beecham's (NYSE: SBH) Hycamtin(TM) (topotecan hydrochloride) received marketing clearance today from the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic ovarian cancer after failure of initial or subsequent chemotherapy. The clearance was based in part on results from an open, randomized comparative study presented to the FDA which showed that patients treated with Hycamtin demonstrated a statistically significantly longer progression-free survival (time to progression) and a numerically superior response rate and median survival than patients treated with paclitaxel (Taxol). "We are extremely pleased that the rapid review will enable women suffering from ovarian cancer to benefit soon from this novel therapy," said Jerry Karabelas, president, SmithKline Beecham Pharmaceuticals North America. "We plan to make Hycamtin available within the next few weeks." Clinical Trials Show Higher Response Rate than Paclitaxel (Taxol) In an open, randomized comparison study, 20 percent of patients receiving Hycamtin responded to treatment compared to 12 percent of patients receiving paclitaxel. Response was defined as 50 percent or greater shrinkage in tumor size. Median progression-free survival or time to progression for all treated patients, defined as the time when the tumor progresses, was both statistically and clinically significant, indicating that patients receiving Hycamtin experienced progressive disease less rapidly -- 23 weeks compared to 14 weeks for paclitaxel. The efficacy of Hycamtin was confirmed in an additional open noncomparative study included in the file submitted to the FDA. In each study, the dosage of Hycamtin was 1.5 mg/m2 administered intravenously over 30 minutes daily for five days and repeated every 21 days. "Ovarian cancer is very difficult to treat and most women die from the disease," said Diane Blum, MSW, executive director of Cancer Care, Inc.(A) "New advances in treating ovarian cancer provide hope to women and we're really pleased to have another option for fighting the disease." Novel Mechanism of Action Provides New Options Hycamtin is the first topoisomerase I inhibitor to be approved for marketing 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. While several anticancer drugs (e.g., etoposide) act by inhibiting the related enzyme topoisomerase II, Hycamtin is the first agent to act against topoisomerase I. Scientists at SmithKline Beecham discovered topotecan HCl in the mid 1980s. Ovarian cancer is the leading cause of gynecologic cancer deaths among American women and will kill an estimated 14,800 women annually.(B) The novel mechanism of action of Hycamtin provides a valuable new tool to treat this deadly disease. After initial therapy, cancer cells frequently become resistant to existing chemotherapies. Hycamtin produced responses after progression with prior chemotherapy used to treat ovarian cancer including platinum compounds and paclitaxel. 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 severe nausea. SmithKline Beecham Oncology Hycamtin is also being studied as a single agent or in combination for a number of other tumor types including small cell lung, breast and colorectal cancers. It is under review with regulatory authorities in other major markets around the world. In addition, SmithKline Beecham has recently initiated a first-line combination chemotherapy study with Hycamtin in patients with ovarian cancer. "We will continue to seek additional indications for Hycamtin as well as additional diagnostic and treatment advances in the battle to treat and eventually cure cancer," said Karabelas. 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. The company has already made important contributions in oncology. First, its anti-emetic research program has yielded the anti-emetics Compazine(R) (prochlorperazine) and Kytril(R) (granisetron hydrochloride). These drugs have become care standards in the treatment of chemotherapy-induced nausea. SmithKline Beecham has ongoing programs in the development and evaluation of novel vaccines and anticancer drugs and the application of genomic technology to improve cancer screening, diagnosis and treatment. SmithKline Beecham (NYSE: SBH) -- one of the world's leading healthcare companies -- discovers, develops, manufactures, and markets pharmaceuticals, vaccines, over-the-counter medicines, and health- related consumer products, and provides healthcare services including clinical laboratory testing, disease management, and pharmaceutical benefit management. (A) Cancer Care, Inc. is the largest agency in the U.S. providing professional counseling, support and education for cancer patients, families and others. (B) ACS Facts and Figures, 1996
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