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
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.