Sanctioned as an orphan drug
THURSDAY, Aug. 9, 2012 (HealthDay News) -- Marqibo (vincristine sulfate liposome injection) has been approved by the U.S. Food and Drug Administration to treat adults with a rare form of blood and bone marrow cancer, Philadelphia chromosome negative acute lymphoblastic leukemia, abbreviated ALL.
The drug is sanctioned for people whose disease has progressed, despite use of at least two anti-leukemia regimens.
ALL is most-often diagnosed in children. The National Cancer Institute estimates that 6,050 people will be diagnosed this year with the disease, and 1,440 will die from it, the FDA said Thursday in a news release.
Marqibo was approved as an orphan drug, designed to treat a rare disease or condition.
The drug was evaluated in a clinical trial of adults whose disease had relapsed at least twice, despite standard anti-leukemia treatments. The most common side effects reported were constipation, nausea, low blood cell count, fever, nerve damage, fatigue, diarrhea, loss of appetite and insomnia.
The drug's labeling will include a boxed warning that the drug must only been administered intravenously, and that it could be lethal if administered in another way.
Marqibo is marketed by San Francisco-based Talon Therapeutics.
The FDA has more about this approval (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm315027.htm ).