Talon seeks market approval for new vincristine formulation

Talon Therapeutics has submitted a new drug application (NDA) to the US FDA seeking accelerated approval of the company's leading drug candidate Marqibo (vincristine sulfate liposomes injection) and it has been accepted for filing.

The FDA will now review Marqibo as a potential treatment for adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy.

Recently, Talon received Special Protocol Assessment (SPA) agreement from the FDA for its proposed Phase III adult front-line study (called HALLMARQ) to treat adults aged 60 or older with newly diagnosed ALL.

Marqibo will also be explored in a Phase I-II clinical study conducted by the National Cancer Institute against pediatric cancers (solid tumors and lymphoid cancers), as well as against newly diagnosed, aggressive Non-Hodgkin's Lymphoma, in the latter case to be conducted by the prestigious German High Grade Non-Hodgkin's Lymphoma Study Group.

Marqibo is a novel, targeted Optisome encapsulated formulation product candidate of the FDA-approved drug vincristine, a chemotherapeutic microtubule inhibitor.