Bristol-Myers Squibb won U.S. approval to sell a new drug called Ixempra for advanced breast cancer, the Food and Drug Administration said.
The company had sought approval to sell the drug, known generically as ixabepilone, for patients whose breast cancer has spread despite prior treatments.
The medicine could generate annual sales of $500 million by 2012, according to industry analysts.
An estimated 160,000 women, and a relatively small number of men, in the United States are diagnosed with breast cancer each year. About 40,000 die of the disease despite treatment with leading current drugs such as Bristol's older Taxol, Sanofi-Aventis' Taxotere and Roche Holding's Xeloda.
Among patients who took Ixempra with Xeloda in clinical trials, tumors either shrank or did not grow for an average of 5.8 months. That was compared to 4.2 months seen for patients taking only Xeloda.
Bristol-Myers shares rose 2 percent in after-hours trade Tuesday after closing at $29.24.