FDA approves new drug for advanced breast cancer

October 17, 2007

WASHINGTON (Reuters) - A new drug called Ixempra 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, according to Bristol-Myers Squibb Co.

Ixempra is part of a new class called epothilones.

The U.S. Food and Drug Administration said on Tuesday it approved Ixempra, known generically as ixabepilone, as a stand-alone treatment for patients with advanced tumors that do not respond to drugs known as anthracyclines and taxanes.

Ixempra was also cleared for use in cancers that don't respond to capecitabine, sold under the trade name Xeloda. In certain patients, it may also be used with Xeloda, the FDA 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.

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.