FDA Approves Marqibo for Rare Leukemia Subtype

The US Food & Drug Administration has granted approval to Talon Therapeutics for Marqibo (vincristine) for the treatment of a rare leukemia subtype under certain conditions.

The FDA has given Marqibo approval as a treatment for Philadelphia-chromosome-negative acute lymphoblastic leukemia (ALL) in adults when the disease has returned two or more times, or when the disease has progressed following two or more anti-leukemia therapy treatments.

ALL is an extremely aggressive cancer. While it is more frequently diagnosed in children, estimates suggest the disease strikes as many as 6,000 adults in the United States each year and that as many as 1,400 succumb to the disease annually.

Marqibo received FDA approval despite a relative dearth of convincing clinical trial evidence of its efficacy. Talon submitted data from three trials featuring a grand total of just 148 patients. Adverse events were reported in a remarkably high percentage of patients as well, perhaps explaining why the FDA's advisory panel was divided about granting a recommendation, and further explaining why the drug received approval for such a narrow disease indication.

Marqibo will arrive with a black boxed warning indicating that any other avenues of administration beyond IV are potentially fatal.

Source: MedPage Today