Talon Therapeutics, Inc, announced the Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain that evidence from clinical studies supports a favorable benefit-risk assessment for use of vincristine sulfate liposomes injection (Marqibo). The manufacturer is seeking an indication for the treatment of adult Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph– ALL) in second or greater relapse or that has progressed following two or more lines of antileukemia therapy. The FDA decision (PDUFA) date for the drug is May 13, 2012.
“We are very pleased the majority of the ODAC members agree that Marqibo offers a meaningful benefit/risk ratio for a very rare patient population that has a grave prognosis and no current standard of treatment,” stated Steven R. Deitcher, MD, President, Chief Executive Officer and Board Member of Talon Therapeutics. “Based on prior FDA discussions, we have received Special Protocol Assessment (SPA) agreement for a large, randomized phase III trial in front-line adult elderly ALL with sites currently open for enrollment. We look forward to working closely with the FDA in the coming weeks to address any remaining questions they may have.”
The new product is a novel, targeted formulation of the FDA-approved anticancer drug vincristine. Talon has been developing the drug for the treatment of adult, Ph– ALL and adult aggressive non-Hodgkin lymphoma. Vincristine, a microtubule inhibitor, is FDA-approved for ALL. Talon’s encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner. ■