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| |  FDA Committee Recommends Hycamtin For Small Cell Lung Cancer GAITHERSBURG, MD -- June 3, 1998 -- The United States Food and Drug Administration’s oncologic drugs advisory committee has recommended the approval of SmithKline Beecham’s Hycamtin(R) (topotecan hydrochloride for injection) for the second-line treatment of sensitive small cell lung cancer. The favourable recommendation was based on a review of data from four clinical trials conducted on patients with relapsed small cell lung cancer. In a randomised, phase III, comparative clinical trial, Hycamtin as a single-agent showed comparable efficacy to CAV, a commonly used triple-drug combination therapy for the treatment of relapsed small cell lung cancer. Median survival and time to progression were also comparable for both treatment groups. Hycamtin is currently approved for use in the treatment of ovarian cancer after failure of initial or subsequent chemotherapy. "Since most small cell lung cancer patients will eventually relapse and become difficult to treat, there is a need for new agents such as Hycamtin that can be used to treat patients, particularly those who have failed first-line therapy,” said Joan Schiller, M.D., associate professor, University of Wisconsin Comprehensive Cancer Center in Madison, WI. and the lead U.S. study investigator for the phase III clinical trial. “There is currently no standard treatment for this malignancy, which is one of the most deadly cancers among both men and women. Results from several clinical trials involving patients treated with Hycamtin have been very encouraging." Lung cancer is the leading cause of cancer death in the U.S. In fact, more people die from lung cancer each year than from colon, prostate and breast cancer combined. Nearly 180,000 people are diagnosed each year, an estimated 25 percent of these diagnoses (45,000 people) are small cell lung cancer. Small cell lung cancer (SCLC) is most common among current or past smokers. Compared to other types of lung cancer, SCLC has a greater tendency to have already spread (metastasised) to other parts of the body by the time a patient is diagnosed with the disease. Approximately two-thirds of all SCLC patients have extensive metastases at the time of diagnosis and nearly all patients with extensive disease will relapse after initial treatment. The panel based its decision in part on a large phase III, randomised clinical trial that was conducted at 44 centres in North America, Europe and South Africa and involved 211 patients who had relapsed at least 60 days after their initial treatment. Patients received either an intravenous infusion of Hycamtin 1.5 mg/m2 as a single agent therapy for five consecutive days every three weeks or CAV (a combination therapy consisting of cyclophosphamide 1,000 mg/m2, doxorubicin 45 mg/m2, and vincristine 2 mg) administered intravenously on day one every three weeks. A greater percentage of Hycamtin-treated patients responded to treatment (24.3 percent versus 18.3 percent), although this difference was not statistically significant. Tumours were assessed by radiologic evaluation and required independent confirmation. Median survival and time to progression were comparable for both treatment groups. Furthermore, more patients treated with Hycamtin reported improvement in disease-related symptoms than patients treated with CAV. A significantly higher percentage of patients who were treated with Hycamtin versus CAV reported an improvement in the following symptoms: shortness of breath, fatigue, hoarseness and anorexia. Improvement was defined as improvement over baseline sustained for at least two consecutive courses. In addition, significantly fewer Hycamtin-treated patients experienced interference with daily activities. Of the other four symptoms measured, improvements were numerically superior for Hycamtin-treated patients (chest pain, cough, insomnia), while improvement in hemoptysis was numerically superior for patients treated with CAV, although this symptom was not very frequent in either group. Data were also reviewed from three open label, non-comparative trials involving 319 patients with recurrent or progressive small cell lung cancer after treatment with first-line chemotherapy. These three studies supported the results of the phase III study. As with many chemotherapeutic agents, the main side effect experienced by Hycamtin in clinical trials was neutropenia (suppression of white blood cells), which was predictable, non-cumulative and manageable. Non-hematologic side effects were generally mild. The most commonly observed events were low-grade nausea, vomiting and diarrhea. Hycamtin is contraindicated in patients who have a history of hypersensitivity reactions to Hycamtin or any of its ingredients. Hycamtin should not be used in patients who are pregnant or breast-feeding, or those with severe bone marrow depression. Hycamtin was the first in a class of drugs known as topoisomerase I inhibitors that kill cancer cells by inhibiting the enzyme topoisomerase I, which is essential in the replication of DNA in human cells. It has undergone extensive study as a single agent and in combination with other drugs in clinical trials in the U.S. and Europe for first and second-line treatment for small cell lung cancer (SCLC). Hycamtin is also under clinical investigation for a number of other cancers including non-small cell lung, breast, colorectal and pediatric cancer, lymphoma, myeloma and leukemia, as well as first-line combination chemotherapy in patients with ovarian cancer. More information on: Hycamtin and SmithKline Beecham.
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