FDA approves Marqibo for rare type of leukemia

Hannah Blake

pharmaphorum

The US Food and Drug Administration (FDA) has approved Marqibo to treat adults with a rare type of leukemia called Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL). This approval gives the San Franciscan drug company, Talon Therapeutics Inc, its first marketed product.

Marqibo (vincristine sulfate liposome injection) has been approved for patients whose leukemia has relapsed two or more times or whose leukemia has progressed following two or more regimens of anti-leukemia therapy.

Marqibo is a liposomal formulation of vincristine sulfate, which is a drug first developed by Eli Lilly &amp, Co in the 1960s. Vincristine is commercially known as Oncovin, and is used in combination with other drugs to treat non-Hodgkin’s lymphoma and acute lymphoblastic leukemia, although the amount that can be given to patients is limited due to the side effects.

"Marqibo’s approval demonstrates the FDA’s commitment to the development and approval of drugs that address serious, unmet medical needs. Marqibo provides an additional option for Philadelphia chromosome negative acute lymphoblastic leukemia patients whose disease is unresponsive to available therapies.”

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

ALL is a rapidly progressing form of blood and bone marrow cancer, which is more commonly diagnosed in children, rather than adults. An estimated 6,050 men and women will be diagnosed with ALL this year, according to the National Cancer Institute.