FDA approves Taxol to treat early-stage breast cancer

October 27, 1999
Web posted at: 12:09 p.m. EDT (1609 GMT)

WASHINGTON (CNN) -- The Food and Drug Administration (FDA) has approved the anti-cancer drug Taxol for the treatment of early stage breast cancer, after clinical studies showed it helped prevent relapses of the disease and significantly boosted survival rates.

Before the FDA action Tuesday night, Taxol already had been approved for the treatment of metastatic or advanced breast cancer as well as lung cancer and ovarian cancer.

Studies following women for 30 months have shown when Taxol is combined with surgery to remove the tumor and standard chemotherapy, there was a 26 percent reduction in death and at 22 percent reduction in disease recurrence.

Scientists say Taxol is the first drug in 20 years to improve the odds for early stage breast cancer.

"It's a very exciting time that we have a treatment that is so effective that we're thinking of using it even in good prognosis patients to take 'good' prognosis and make 'great' prognosis," said Dr. Larry Norton, Memorial Sloan-Kettering Cancer Center.

Taxol regimen easier on patients

Studies show the Taxol-surgery-chemotherapy regimen is easier to tolerate than chemotherapy and surgery alone.

Specifically, the new treatment regimen is approved for women who have early stage node-positive breast cancer, that is breast cancer that has spread to the lymph nodes but no further. It's estimated this includes up to 40 percent of women with newly diagnosed breast cancer.

According to the American Cancer Society, there will be 175,000 new cases of breast cancer diagnosed this year in the United States.

Taxol, which was originally isolated from the Pacific Yew Tree is produced by Bristol Myers Squibb.