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Back To Vidyya FDA Approves Novantrone For Treating Advanced Multiple Sclerosis

Novantrone Could Reduce The Number Of Relapse Episodes And Decrease The Progression Of Disability

The FDA has approved Novantrone (mitoxantrone), an approved cancer drug, for treating patients with advanced or chronic Multiple Sclerosis (MS), a disease that attacks the nervous system and can cause weakness, impaired vision, loss of balance, and poor muscle coordination. MS can have different patterns, sometimes leaving patients relatively well after episodes of acute worsening, sometimes leading to progressive disability that persists after episodes of worsening. In the worst cases the disease can lead to paralysis.

Two randomized multi-center clinical studies, totaling about 200 patients, demonstrated that Novantrone could reduce the number of relapse episodes and decrease the progression of disability in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting MS (all forms of the disease in which patients become significantly more abnormal between relapses as time passes). The trials showed that Novantrone can help reduce the number of relapses and help patients keep their mobility longer.

This drug has not been studied in, and is not approved for treatment of primary progressive MS, a form of MS in which the patientís neurologic condition deteriorates over time without specific relapses. The approval of Novantrone is the first approval of an anticancer drug for treatment of multiple sclerosis. Other approved treatments are several beta interferons, Copaxone (which also decreases the number of relapses, and Avonex (which has been shown to slow the accumulation of physical disability in addition to decreasing the number of relapses). Novantrone is also approved for treating patients with pain related to advanced hormone-refractory prostate cancer and, in combination with other drugs, in the initial therapy of acute nonlymphocytic leukemia in adults.

Some patients treated with Novantrone may develop heart problems that can be very serious. The risk of heart disease increases with the cumulative dose, and patients with MS should ordinarily not receive more than 8 to 12 doses administered over two to three years. The professional labeling and patient information recommend that doctors closely monitor their patients. Patients will be advised that regular testing of heart and blood is needed to help avoid serious side effects. The most frequent side effects include nausea, hair thinning, loss of menstrual periods, bladder infections and mouth sores.

Novantrone is manufactured for Immunex Corporation, Seattle, Wash., by Lederle Labs.


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Editor: Susan K. Boyer, RN
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