Talon Therapeutics' Marqibo(R) (vinCRIStine Sulfate LIPOSOME Injection) Granted Accelerated Approval By FDA
SOUTH SAN FRANCISCO, Calif., Aug. 9, 2012 (GLOBE NEWSWIRE) -- Talon Therapeutics today announced Marqibo ® (vinCRIStine sulfate LIPOSOME injection) received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified. Marqibo is administered at a dose of 2.25 mg/m 2 intravenously over 1 hour once every 7 days. Marqibo has different dosage recommendations than non-liposomal vincristine sulfate.
"We are delighted that Marqibo will be available to a patient population with an underserved hematologic malignancy," stated Steven R. Deitcher MD, President, Chief Executive Officer and Board Member of Talon Therapeutics. "This represents a transformational event for Talon and fulfillment of our most important corporate goal, to date."
About Marqibo ®Marqibo is a novel, sphingomyelin/cholesterol liposome-encapsulated, formulation of vincristine sulfate. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and Non-Hodgkin's Lymphoma (NHL) and is widely used in combination regimens for treatment for a variety of adult and pediatric hematologic and solid tumor malignancies. The Optisome™ nanoparticle encapsulation technology, utilized by Talon, has been shown to provide prolonged circulation of vincristine in the blood. Marqibo has received orphan drug designation for the treatment of ALL from the FDA and from the European Medicines Agency (EMA). Talon intends to submit a Marketing Authorization Application to the EMA in 2013. Please see important safety information below and the full prescribing information for Marqibo at www.marqibo.com . Indication and usage Marqibo is a liposomal vinca alkaloid indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progresses following two or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified.
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