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These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):
• Azacitidine (Vidaza) by Pharmion Corp. The FDA has approved azacitidine (Vidaza) injection for the first treatment of patients with myelodysplastic syndrome (MDS). The product was given fast-track status and a priority review. Azacitidine also is an orphan product. This approval gives Pharmion a seven-year period of exclusive marketing for the drug.
Azacitidine is thought to work by restoring normal growth and differentiation of bone marrow cells. The safety and effectiveness of azacitidine, in the treatment of all subtypes of MDS, were established in a randomized, controlled trial and in two nonrandomized studies in a total of 268 patients. About 15% of patients in the three trials had complete or partial responses to azacitidine. Responses consisted of complete or partial normalization of blood counts and of immature cell percentages in the bone marrow. In responders, the need for transfusions was eliminated.
The most common adverse events reported in clinical trials included nausea, anemia, thrombocytopenia (low platelets in blood), diarrhea, fatigue, irritation at the injection site, and constipation.
• New indication for docetaxel (Taxotere) by Aventis Pharmaceuticals. The FDA has approved docetaxel (Taxotere) injection, in combination with prednisone, for the treatment of patients with advanced metastatic prostate cancer. This is the first drug approved for hormone refractory prostate cancer that has shown a survival benefit.
Docetaxel works by inhibiting tubulin, a protein essential to cell division, thus preventing cancer cells from dividing and growing in number.
The safety and effectiveness of docetaxel was established in a randomized, multicenter global clinical trial with more than 1,000 patients comparing chemotherapy with docetaxel and prednisone to mitoxantrone and prednisone in men with metastatic, hormone-refractory prostate cancer. Docetaxel, in combination with prednisone, given every three weeks, showed a survival advantage of approximately 2.5 months over the control group in the trial.
The most common adverse events reported were nausea, alopecia, and bone marrow suppression. In addition, fluid retention and peripheral neuropathy, known effects of docetaxel, were also observed.
• Paricalcitol injection (Zemplar) by Abbott Laboratories for pediatric use. The FDA has approved paricalcitol injection (Zemplar) for use in children and adolescent hemodialysis patients, ages 5-19, with secondary hyperparathyroidism (SHPT). Paricalcitol initially was introduced in 1998 and currently is used to treat SHPT in the majority of adult dialysis patients in the United States.
The safety and effectiveness of paricalcitol were examined in a 12-week randomized, double-blind, placebo-controlled study of 29 pediatric patients, ages 5 to 19 years, with chronic renal failure on hemodialysis. Nearly all had received some form of vitamin D therapy prior to the study.
Paricalcitol is contraindicated in patients with vitamin D toxicity, hypercalcemia, or hypersensitivity to product ingredients.