New FDA Approvals
New FDA Approvals
The following drugs recently received approval from the U.S. Food and Drug Administration in Rockville, MD.
• Camptosar for colorectal cancer: Pharmacia in Peapack, NJ, has received approval for Camptosar (irinotecan hydrochloride injection) as first- line therapy for the treatment of patients with metastatic colorectal cancer in combination with 5-fluorouracil/leucovorin (5-FU/LV).
The FDA approval is based on data from two phase III studies which demonstrated the potential of Camptosar to prolong patients’ lives when used in combination with 5-FU/LV as a first-line treatment for metastatic colorectal cancer, compared with 5-FU/LV alone. Those studies, conducted primarily in North America and Europe, demonstrated prolonged median survival and significantly longer time to tumor progression for the regimen of Camptosar and 5-FU/LV, compared with 5-FU/LV alone.
For patient product information, call (888) 691-6813.
• Novantrone reduces MS-related disability: Immunex in Seattle has been approved for Novantrone (mitoxantrone for injection concentrate) as the first therapy approved for secondary-progressive multiple sclerosis (MS). Novantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary-progressive, progressive-relapsing, or worsening relapsing-remitting MS.
FDA approval is based on results from a 24-month phase III clinical trial in which Novantrone 12 mg/m2 was administered by short infusion once every three months. This trial demonstrated that it had a statistically significant impact on prolonging time to first-treated relapse and on delaying disability progression in patients with secondary-progressive or progressive-relapsing MS.
Patients in the Novantrone group experienced a significant reduction in the mean number of treated relapses. They also experienced a significant reduction in new MS lesions seen on magnetic resonance imaging. Patients taking the drug may develop serious heart problems. To measure potential heart changes, patients should receive regular testing of their heart’s ability to pump blood. In addition, due to risk of heart injury, there is a limit to the total lifetime amount of Novantrone a patient should receive. For most patients, the lifetime total is roughly eight to 12 doses over two to three years.
For more details, visit www.novantrone.com or www.immunex.com or receive full prescribing information by calling (800) 566-8268.
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