The US Food and Drug Administration (FDA) has granted accelerated approval to Talon Therapeutics' Marqibo (vinCRIStine sulfate LIPOSOME injection).
Marqibo, a sphingomyelin/cholesterol liposome-encapsulated formulation of vincristine sulfate, is administered at a dose of 2.25 mg/m2 intravenously over 1 hour once every 7 days.
Marqibo is intended for treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.
Talon has utilized the optisome nanoparticle encapsulation technology in Marqibo formulation to provide prolonged circulation of vincristine in the blood.
The company is planning to submit a marketing authorization application to the European Medicines Agency in 2013.
Talon Therapeutics chief executive officer and president Steven Deitcher said the company is delighted that Marqibo will be available to a patient population with an underserved hematologic malignancy.
"This represents a transformational event for Talon and fulfillment of our most important corporate goal, to date," Deitcher added.