NEW YORK (Reuters) - U.S. health regulators have granted priority review for Bristol-Myers Squibb Co.'s experimental breast cancer drug ixabepilone, and an approval decision on the medicine could come by late October, the company said on Tuesday.
With priority review status, the U.S. Food and Drug Administration will make its decision on whether to approve the drug within six months, rather than the usual 10- to 12-month review period. The agency grants priority review to products that are considered to be potentially significant advancements over existing therapies.
Bristol-Myers is seeking approval for ixabepilone to treat advanced breast cancer patients who have not responded to prior treatment with chemotherapies.
In data from a clinical trial presented earlier this month at a major cancer meeting, ixabepilone and chemotherapy were significantly better than chemotherapy alone in delaying progression of advanced breast cancer.
Following treatment, 35 percent of those receiving the drug combination experienced at least a 50 percent reduction in tumor size. That compared with 14 percent of patients receiving chemotherapy alone. The better result was highly statistically significant, meaning it was compelling.
Ixabepilone belongs to a new class of drugs called epothilones that Bristol-Myers hopes will prove better able than standard drugs to thwart resistance by tumors.
The drug is a semi-synthetic version of a compound isolated from an African soil sample.
Women diagnosed with advanced breast cancer will be most interested in this news. The U.S. Food and Drug Administration (FDA) has decided to speed up its review process of a new breast cancer chemotherapy medication, ixabepilone (icks-a-behp-ih-loan). A faster review process makes it likely that this new medication will be approved by the end of 2007 to treat advanced breast cancer after other chemotherapy treatments have failed.
At the 2007 American Society of Clinical Oncology annual meeting, researchers presented study results showing that women with advanced breast cancer who were not responding to standard chemotherapy treatment had a better response when ixabepilone was added to the chemotherapy regimen.
Ixabepilone belongs to a new class of chemotherapy medications called epothilones. Ixabepilone works a lot like chemotherapies known as taxanes (Taxol and Taxotere are both taxanes). Ixabepilone and taxanes work against cancer by interfering with the way cancer cells divide and multiply. Researchers think that ixabepilone might work better against advanced breast cancer than other chemotherapies because it may be harder for cancers to stop responding to ixabepilone.
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.
To learn more about treatment resistance and why different medications are usually needed to treat breast cancer, visit breastcancer.org's "Why So Many Types of Breast Cancer Treatments?" page.
This article was made possible by an educational grant from GlaxoSmithKline.
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