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

Main Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Oct 2007 - 6:00 PDT

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An FDA spokesperson on Tuesday said the agency approved Bristol-Myers Squibb's chemotherapy drug Ixempra for use as a breast cancer treatment for women who have not responded to other treatments, as well as for use in combination 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 of cancerous cells, and stop cancer cells from growing and dividing (Jordon, Newark Star-Ledger, 10/17).

Clinical Trials, Reaction
FDA's approval was based on two clinical trials that evaluated the drug alone and in combination with Xeloda among 878 women with spreading or locally advanced breast cancer, the AP/CNNMoney.com reports (AP/CNNMoney.com, 10/16). In a study that evaluated the drug in combination with Xeloda, progression-free survival was 5.8 months among women taking the combination therapy, compared with 4.2 months in the Xeloda-only group. About 23% of patients taking the combination therapy experienced neuropathy, compared while none of the patients experienced the 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.

Potential side effects of the drug include bone marrow suppression, constipation, nausea, vomiting, muscle and joint pain, fatigue and weakness, and tingling or numbness in the hands and feet, FDA spokesperson Christopher 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 in the 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 College who was involved in the drug's trials -- said, "The approval of Ixempra means that we now have an important new option for patients with metastatic breast cancer who have rapidly progressed through currently approved chemotherapies." An estimated 160,000 women in the U.S. are diagnosed with breast cancer annually, and about 40,000 die despite treatment with current drugs, the Star-Ledger reports (Newark Star-Ledger, 10/17).

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