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Product Discovery & Development
After 20 years, 2 companies and 1 rejection, FDA approves Marqibo for leukemia
Clawing towards approval
Monday, August 20, 2012
After 20 years in development at two companies, Marqibo
vincristine sulfate received accelerated approval from FDA this month
Therapeutics Inc. applied the lessons from a previous rejection by
conducting a more thoroughly adjudicated study in a new cancer setting. Talon
plans to launch the drug for late-stage acute lymphoblastic leukemia in 1Q13.
Marqibo is a nanoparticle-encapsulated
formulation of vincristine designed to allow for dose intensification of the
vinca alkaloid to facilitate activity against relapsed or refractory cancer
without exacerbating toxicities.
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