ROCKVILLE, MdThe Food and Drug Administration has approved a
new indication for Bristol-Myers Squibbs 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 FDAs 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
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 Kaposis sarcoma; and in
combination with cisplatin for the first-line treatment of
non-small-cell lung cancer.