FDA Approves Bristol-Myers Squibb Late-Stage Breast Cancer Drug Ixempra

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An FDA spokesperson on Tuesday said the agency approved Bristol-Myers Squibb'schemotherapy drug Ixempra for use as a breast cancer treatment forwomen who have not responded to other treatments, as well as for use incombination with Roche's chemotherapy drug Xeloda as late-stage breast cancer treatment, the Wall Street Journal reports.

The drug, known generically as ixabepilone, falls into a new class of drugs known as epothilones (Corbett Dooren, Wall Street Journal, 10/16). According to the Newark Star-Ledger,Ixempra aims to disrupt the formation of microtubules, the skeleton ofcancerous cells, and stop cancer cells from growing and dividing(Jordon, Newark Star-Ledger, 10/17).

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Clinical Trials, Reaction

FDA's approval was based on two clinical trials that evaluated the drugalone and in combination with Xeloda among 878 women with spreading orlocally advanced breast cancer, the AP/CNNMoney.comreports (AP/CNNMoney.com, 10/16). In a study that evaluated the drug incombination with Xeloda, progression-free survival was 5.8 months amongwomen taking the combination therapy, compared with 4.2 months in theXeloda-only group. About 23% of patients taking the combination therapyexperienced neuropathy, compared while none of the patients experiencedthe condition in the Xeloda-only group (Wall Street Journal, 10/16). According to Reuters, the two trials are expected to determine by 2008 whether the drug extends survival rates.

Potentialside effects of the drug include bone marrow suppression, constipation,nausea, vomiting, muscle and joint pain, fatigue and weakness, andtingling or numbness in the hands and feet, FDA spokespersonChristopher DiFrancesco said (Richwine, Reuters, 10/16).BMS said it will make Ixempra available within days (AP/CNNMoney.com,10/16). Robert LaCaze, BMS' vice president for oncology marketing inthe U.S., said a course of Ixempra treatments will be priced between$18,000 and $23,000.

Linda Vahdat -- associate professor of clinical medicine at Weill Cornell Medical Collegewho was involved in the drug's trials -- said, "The approval of Ixemprameans that we now have an important new option for patients withmetastatic breast cancer who have rapidly progressed through currentlyapproved chemotherapies." An estimated 160,000 women in the U.S. arediagnosed with breast cancer annually, and about 40,000 die despitetreatment with current drugs, the Star-Ledger reports (Newark Star-Ledger, 10/17).

Reprinted with permission from kaisernetwork.org. You can view theentire Kaiser DailyWomen's Health Policy Report, search the archives, and sign up for emaildelivery at kaisernetwork.org/email. The Kaiser Daily Women's Health Policy Report is published for kaisernetwork.org, afree service of The Henry J. Kaiser Family Foundation.

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