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| |  Hycamtin Recommended for Approval by FDA for Recurrent Ovarian Cancer BETHESDA, Md., April 19, 1996 -- The Oncologic Drugs Advisory Committee of the Food and Drug Administration today unanimously recommended approval of Hycamtin(TM) (topotecan hydrochloride) from SmithKline Beecham (NYSE: SBH) 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. While several anticancer drugs act by inhibiting the related enzyme topoisomerase II (e.g., etoposide), Hycamtin is the first agent to act against topoisomerase I. Hycamtin's novel mechanism of action provides a valuable new option for prolonging the life of ovarian cancer patients. In treating recurrent ovarian cancer, cures are rare. When the cancer reappears, drug resistance is a common problem as cancer cells frequently grow back with an increased resistance to existing chemotherapies. Hycamtin produced responses after progression with other chemotherapy including platinum and paclitaxel used to treat ovarian cancer. 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. Clinical Trials Show Higher Response Rate than Paclitaxel (Taxol) In an open, randomized comparison study, 21 percent of patients who received Hycamtin responded to treatment compared to 13 percent of patients receiving paclitaxel. Response was defined as 50 percent or greater shrinkage in tumor size. In addition, the median duration of response for patients on Hycamtin was 32 weeks compared to 20 weeks for those on paclitaxel. Duration of response was defined as the time from when a patient first responds to treatment to the time the cancer progresses. 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 the two additional open noncomparative studies included in the file submitted to the committee. 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. "We are extremely pleased with the Hycamtin data which resulted in the committee's positive decision today," said Colin Broom, M.D., group director, oncology, SmithKline Beecham. "There is a desperate need for more effective second-line treatments that offer women with recurrent ovarian cancer a hope of prolonged survival." Side Effects Manageable and Predictable 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. In the combined ovarian cancer studies, 18 of 445 (4.0%) patients withdrew from study due to such hematologic and/or infective complications. The most frequently reported non-hematologic side effects were gastrointestinal, including nausea and vomiting. Ovarian Cancer Rarely Cured Because ovarian cancer is almost completely asymptomatic in its early stages and screening methods are inadequate, three-fourths of all cases remain undetected until the tumor has spread beyond the ovaries. Surgical removal of the tumor is the standard initial treatment for ovarian cancer. However, a majority of patients undergo chemotherapy at some stage of the disease, as surgery alone is rarely curative. The most frequently used chemotherapy agents for first-line treatments include cisplatin, carboplatin, paclitaxel or cyclophosphamide, usually in combination. Some ovarian cancers will persist despite early and aggressive intervention. In addition, approximately 30 to 50 percent of women will ultimately relapse after a complete remission. At this stage, the role of effective second-line therapies with different mechanisms of attack such as Hycamtin is crucial, as by the time the cancer reappears it may have become resistant to most first- line therapies. SmithKline Beecham Oncology Hycamtin is also being studied for a number of other tumor types. 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. 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.
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