To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Shorter Regimen For Cancer Drug Taxol (Paclitaxel) URL: http://www.pslgroup.com/dg/1D92F6.htm Doctor's Guide July 11, 2000
PRINCETON, NJ -- July 11, 2000 -- Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration has approved a novel, shorter administration regimen for Taxol (paclitaxel) injection for the treatment of advanced ovarian cancer. The FDA granted approval for this new dosing regimen based on results from a multi-national, phase III randomized clinical trial. The new regimen recognizes the greater effectiveness of Taxol at a dose of 175 mg/m2 in combination with cisplatin (75 mg/m2) in a three-hour regimen every three weeks as compared to the standard therapy (cyclophosphamide 750 mg/m2 followed by cisplatin 75 mg/m2). Taxol is also approved for use in advanced ovarian cancer at 135 mg/m2 over a 24-hour infusion period given in combination with cisplatin (75 mg/m2) every three weeks. The new three-hour regimen offers patients the advantage that it can be administered in the outpatient setting, avoiding hospitalization. "The results from this study confirm that Taxol (paclitaxel) in combination with cisplatin provides a significant survival benefit compared to the previous cisplatin plus cyclophosphamide standard regimen," said Renzo Canetta, vice president, clinical oncology research, Bristol-Myers Squibb Pharmaceutical Research Institute. "We are very excited that women will now have the opportunity to receive Taxol at a higher dose in a shorter, more convenient, three-hour dosing schedule." The registrational (OV-10/BMS CA139/209) trial for this indication, conducted by a Canadian-European consortium of cooperative groups, enrolled 680 women with (stage IIb through stage IV) ovarian cancer to receive treatment with either Taxol/cisplatin or cisplatin/cyclophosphamide. Women in this trial were randomized to receive Taxol at 175 mg/m2 followed by cisplatin at 75 mg/m2 in a three-hour infusion every three weeks or cyclophosphamide (750 mg/m2) followed by cisplatin (75 mg/m2) over three hours, every three weeks for a median of six courses. Women in the Taxol arm of the study experienced significantly improved overall survival (35.6 months) compared to women in the cyclophosphamide arm (25.9 months). Further, progression-free survival was significantly higher for the women who received the Taxol regimen compared to the cyclophosphamide regimen (15.3 months versus 11.5 months). Progression-free survival in the Taxol arm of the study remained significantly greater even after considering prognostic factors such as age, stage of disease, grade of disease and residual disease. Also, response rates were higher in the Taxol arm. Notably, a large number of patients in the cyclophosphamide arm with progressive disease were subsequently treated with a Taxol-based therapy. "These data confirm that Taxol in combination with cisplatin, once again, positively impacts survival in women with ovarian cancer," said Peter Ringrose, president, Pharmaceutical Research Institute, Bristol-Myers Squibb. "This is just another example of our continuing efforts to develop Taxol to its fullest potential. Taxol continues to be studied in a variety of cancers." The pivotal study confirmed the safety of a three-hour Taxol infusion with cisplatin and demonstrated that this combination resulted in a lower incidence of severe neutropenia (reduction in white blood cells) than cyclophosphamide/cisplatin (33 percent vs. 43 percent, respectively). The incidence of myalgia/arthralgia and severe neurotoxicity with Taxol/cisplatin, however, was greater than in the cyclophosphamide/cisplatin group (60 percent vs. 27 percent vs. 21 percent vs. 27 percent, respectively). Other side effects were reduction of red blood cells (anemia), nausea and vomiting, joint and muscle pain and infection. Severe hypersensitivity reaction which can be fatal can also occur with Taxol, demonstrated by shortness of breath, low blood pressure and rash. All patients receiving Taxol should be premedicated, as described in the package insert, to help prevent this allergic reaction. Taxol should not be given to patients with a history of allergic reactions to Taxol or other drugs formulated with Cremaphor El (polyoxyethylated castor oil). These results confirm that the short infusion of Taxol, in a cisplatin-based regimen, is a viable alternative in the modern treatment of ovarian cancer and that this short infusion developed by Bristol-Myers Squibb offers patients another option in receiving therapy that is significantly superior in efficacy to the standard therapy. Paraplatin® (carboplatin for injection), also developed by Bristol-Myers Squibb, is another platinum compound approved for the initial treatment of advanced ovarian cancer in combination with other approved chemotherapy drugs. The most serious side effects associated with Paraplatin include a reduction in red blood cell counts and platelets, which may be severe enough to require transfusions. Reductions in white blood cell counts may cause infections to occur. Allergic reactions may occur and may be severe. Other side effects include nausea, vomiting, pain and weakness. 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