The U.S. Food and Drug Administration (FDA) approved Ixempra (chemical name: ixabepilone -- pronounced icks-a-bep-ih-loan) to treat advanced breast cancer after other chemotherapy treatments have stopped working. Ixempra was approved to be given either alone or in combination with Xeloda (chemical name: capecitabine).
Research has shown that advanced breast cancers that were not responding to standard chemotherapy treatments had a better response when Ixempra was used. Compared to Xeloda alone, giving Ixempra with Xeloda stopped the cancer's progression longer. It's not clear yet whether using Ixempra can actually improve survival in women diagnosed with advanced breast cancer.
Ixempra belongs to a new class of medicines called epothilones. Ixempra works a lot like the taxanes (Taxol, Abraxane, and Taxotere are all taxanes). Ixempra and the taxanes work against cancer by interfering with how the cancer cells divide and multiply. Researchers think that Ixempra might work better against advanced breast cancer than some other chemotherapy medicines because it may be harder for cancers to stop responding to Ixempra.
When a cancer stops responding to a treatment that used to work, doctors say the cancer has become resistant to that treatment. Resistance happens when cancer cells figure out how to survive against treatments. This might happen when a treatment kills the cells it can, but doesn't work against EVERY cancer cell. The cells that survive treatment are called resistant cells. These resistant cells eventually grow. Sometimes more courses of the same treatment, maybe at a higher dose, might be able to get rid of all the resistant cancer cells. But sometimes different treatments are necessary. So a chemotherapy that makes it harder for cancer cells to resist treatment could be a good option.
Stay tuned to breastcancer.org for the latest news on breast cancer treatment options.
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.
(Additional reporting by Bill Berkrot in New York)
Breastcancer.org 7 East Lancaster Avenue, 3rd Floor Ardmore, PA 19003
Learn more about our commitment to your privacy
© 2009 Breastcancer.org - All rights reserved.
Breastcancer.org is a non-profit organization dedicated to providing information and community to those touched by this disease. Learn more about our commitment to providing complete, accurate, and private breast cancer information.
