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
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
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."