COLLEGEVILLE, Penn--Rhône-Poulenc Rorer Inc. has received clearance from the US Food and Drug Administration to market Taxotere (docetaxel) for Injection Concentrate.
The indication is for treatment of patients who have locally advanced or metastatic breast cancer that has progressed during anthracycline-based therapy or has relapsed during anthracycline-based adjuvant therapy.
In worldwide phase II clinical trials, Taxotere demonstrated the highest tumor response rates ever reported for a single agent in this patient population, the company said.
"Taxotere is an important new therapy that will greatly enhance our ability to control the cancer of women with advanced-stage breast cancer," said Gabriel Hortobagyi, MD, of The University of Texas M.D. Anderson Cancer Center.
"Based on my clinical experience," he said, "chemotherapy agents currently used in this difficult-to-treat patient population produce tumor response rates of 6% to 29%. In our clinical trials, Taxotere demonstrated a 47% response rate at the 100 mg/m² dose."
The approved outpatient regimen is 60 to 100 mg/m² given intravenously for 1 hour every 3 weeks. According to Rhône-Poulenc Rorer, Taxotere can be given on an outpatient basis, eliminating costly hospital stays and allowing patients to spend more time at home.
Said Kathy Troumer, RN, Marin Oncology Associates, Greenbrae, Calif, "Our experience has shown that, with everything they have gone through, these patients appreciate the opportunity to spend more time at home with their family and friends as they continue their chemotherapy."