FDA Approves Taxol as Adjuvant Therapy for Node+ Breast Cancer

ROCKVILLE, Md—The Food and Drug Administration has approved a new indication for Bristol-Myers Squibb’s Taxol (paclitaxel) for use in the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-based combination therapy. The approval does not exclude patients with receptor-positive tumors, even though a subgroup analysis of the supporting data suggested no benefit in this group.

The approval came only a month after a unanimous recommendation for approval by the FDA’s Oncologic Drugs Advisory Committee (ODAC). (See Oncology News International, October 1999, page 4, for a full report of the meeting.)

At the ODAC meeting, Bristol-Myers Squibb presented data on more than 3,000 patients in a randomized phase III study. The results showed that the adjuvant use of Taxol reduced the risk of breast cancer recurrence in node-positive patients by 22% and reduced mortality by 28%, compared with patients who received doxorubicin-based chemotherapy alone.

The indication states: “In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone negative tumors.”

The agent was first approved in the United States in late 1992 for the second-line treatment of ovarian cancer. It has since won approval for use in breast cancer after failure of combination chemotherapy for metastatic disease; for the first-line treatment of ovarian cancer in combination with cisplatin (Platinol); for the second-line treatment of AIDS-related Kaposi’s sarcoma; and in combination with cisplatin for the first-line treatment of non-small-cell lung cancer.