Bendeka Approved for Chronic Lymphocytic Leukemia and Indolent B-Cell Non-Hodgkin Lymphoma
December 8, 2015 – The U.S. Food and Drug Administration (FDA) approved Bendeka (bendamustine), manufactured by Eagle Pharmaceuticals and Teva. Bendeka is indicated for the treatment of chronic lymphocytic leukemia (CLL) and to treat indolent B-cell non-hodgkin lymphoma (NHL) that has progressed during or within six months with rituximab (Rituxan – Genentech) or a rituximab-containing regimen. The recommended dose for CLL is 100mg/square meter of body surface area (m2) per day on the first two days of each 28-day treatment cycle for up to six cycles. For NHL the recommended dose is up to eight cycles of 120mg/m2 per day on the first two days of 21-day treatment cycles. Dosage forms available are 4mL multi-dose vials containing 100mg of bendamustine, to be given in treatments as 10-minute intravenous (IV) infusions of Bendeka mixed with 50mL of IV fluid. Results from clinical trials showed that 98% of patients receiving Bendeka experienced severe myelosuppression which is the decreased ability of bone marrow to produce blood cells. Therefore, blood counts need to be monitored when taking Bendeka, as doses may need to be reduced or delayed if blood counts do not reach adequate levels before the next scheduled treatment cycle. Bendeka is expected to be launched in the first quarter of 2016 through a limited specialty network.
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