Taxotere Gets FDA Approval for Treatment of Advanced Breast Cancer

COLLEGEVILLE, Penn--Rhône-Poulenc Rorer Inc. has receivedclearance from the US Food and Drug Administration to market Taxotere(docetaxel) for Injection Concentrate.

The indication is for treatment of patients who have locally advancedor metastatic breast cancer that has progressed during anthracycline-basedtherapy or has relapsed during anthracycline-based adjuvant therapy.

In worldwide phase II clinical trials, Taxotere demonstrated thehighest tumor response rates ever reported for a single agentin this patient population, the company said.

"Taxotere is an important new therapy that will greatly enhanceour ability to control the cancer of women with advanced-stagebreast cancer," said Gabriel Hortobagyi, MD, of The Universityof Texas M.D. Anderson Cancer Center.

"Based on my clinical experience," he said, "chemotherapyagents currently used in this difficult-to-treat patient populationproduce tumor response rates of 6% to 29%. In our clinical trials,Taxotere demonstrated a 47% response rate at the 100 mg/m²dose."

The approved outpatient regimen is 60 to 100 mg/m² givenintravenously for 1 hour every 3 weeks. According to Rhône-PoulencRorer, Taxotere can be given on an outpatient basis, eliminatingcostly hospital stays and allowing patients to spend more timeat home.

Said Kathy Troumer, RN, Marin Oncology Associates, Greenbrae,Calif, "Our experience has shown that, with everything theyhave gone through, these patients appreciate the opportunity tospend more time at home with their family and friends as theycontinue their chemotherapy."