New FDA Approvals
New FDA Approvals
These drugs and/or new indications have received final approval from the U.S. Food and Drug Administration:
- Breast cancer therapy Ellence (epirubicin hydro chloride) by Pharmacia & Upjohn. Indicated for adjunct therapy in cases of axillary node presence following surgical removal of primary breast cancer, approval of the injectable therapy followed two combination clinical trials resulting in heightened survival and decreased risk of relapse. The trials involved cycles of epirubicin in combination with fluorouracil and cyclophosphamide compared to the latter two drugs in combination with methotrexate.
- Organ rejection treatment Rapamune (sirolimus) by Wyeth-Ayerst. Indicated specifically for renal transplant therapy, approval is for combination use with cyclosporine and corticosteroids. The drug’s mechanism inhibits the activation of kinase involved in cell cycle progression toward the suppression of cytokine-induced T-lymphocyte proliferation. Approval follows a placebo-controlled trial of 576 patients resulting in rejection rates of 30% on the combination vs. 47.7% in the placebo group. Adverse reactions from trials included increased cholesterol and triglyceride levels, hypertension, and rash.
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