October 16, 2007 / 9:21 PM / 12 years ago

FDA approves Bristol-Myers breast cancer drug

WASHINGTON (Reuters) - A new chemotherapy drug called Ixempra made by Bristol-Myers Squibb Co for women with advanced breast cancer that does not respond to other therapies has won U.S. approval to be sold and is expected to be available in days.

Known generically as ixabepilone, the drug could generate annual sales of $500 million by 2012, according to industry analysts.

The U.S. Food and Drug Administration said on Tuesday it approved Ixempra as a stand-alone treatment for patients with advanced tumors that do not respond to Roche Holding AG’s Xeloda or drugs known as anthracyclines or taxanes.

It also was cleared for use with Xeloda certain advanced breast cancer patients, the FDA said and Bristol-Myers said.

“We now have an important new option for patients with metastatic breast cancer who have rapidly progressed through currently approved chemotherapies,” Dr. Linda Vahdat, a cancer expert at New York-Presbyterian Hospital/Weill Cornell Medical Center, said in a Bristol-Myers statement.

For most patients the total cost of a full course of Ixempra is expected to run from $18,440 to $23,050, Bristol-Myers spokesman Tony Plohoros said.

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 Xeloda.

Ixempra, a chemotherapy drug designed to kill cancer cells, is part of a new class called epothilones.

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.

Two ongoing trials are expected to determine by late 2008 whether Ixempra actually extends survival.

Potential side effects from Ixempra include tingling or numbness in the hands and feet, bone-marrow suppression, constipation, nausea, vomiting, muscle pain, joint pain, fatigue and weakness, FDA spokesman Christopher DiFrancesco said.

The combination of Ixempra and Xeloda should not be given to patients with moderate to severe liver failure because of an increased risk of toxicity and death, DiFrancesco said.

(Additional reporting by Bill Berkrot in New York)

Editing by Jeffrey Benkoe/Carol Bishopric/Toni Reinhold; Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691

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