FDA approves Marqibo to treat rare type of leukaemia

Published: 10-Aug-2012

Orphan drug approved under agency’s accelerated approval programme


The US Food and Drug Administration (FDA) has approved Talon Therapeutics’ Marqibo (vincristine sulfate liposome injection), a treatment for adults with a rare type of leukaemia known as Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).

ALL is a rapidly progressing form of blood and bone marrow cancer that is more commonly diagnosed in children than adults.

The FDA has approved Marqibo for patients whose leukaemia has relapsed two or more times, or whose leukaemia has progressed following two or more regimens of anti-leukaemia therapy.

The treatment contains vincristine, a commonly used anti-cancer drug, encased within a liposome, a drug delivery vehicle composed of material similar to that of cell membranes. It is an injection administered once a week by a healthcare professional.

Steven Deitcher, president and ceo of Talon Therapeutics, said: ‘We are delighted that Marqibo will be available to a patient population with an under-served haematologic malignancy.

‘This represents a transformational event for Talon and fulfilment of our most important corporate goal, to date.’

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