NEW YORK, Oct 27 (Reuters Health) -- The Food and Drug Administration (FDA) approved Bristol-Myers Squibb's drug Taxol (paclitaxel) for use in treating early-stage, node-positive breast cancer.
"It will have a significant impact on how women with this stage of cancer are treated," said John Kouten, a spokesperson for the company, in a statement.
Taxol is approved for use in breast cancer patients who have received doxorubicin-based chemotherapy.
The FDA approval follows a unanimous September recommendation for approval of this indication by an advisory panel to the agency. As reported by Reuters Health on September 20, studies on more than 3,000 patients demonstrated that Taxol cut the risk of recurrence of node-positive breast cancer by 20% and reduced mortality by 26%.
Taxol was previously approved for marketing in the US for some advanced cancers and lung and ovarian cancers. The drug generated revenues of around $1.2 billion in 1998.
Although approval for this indication is not expected to have a major sales impact, Gruntal & Company drug analyst David Saks said that the approval would add "to the depth and breadth of Taxol." He added, "The drug has become ubiquitous in chemotherapy."
In Wednesday afternoon trade, shares in New York-based Bristol-Myers Squibb climbed 1-7/8 to 73-15/16.
