Clawing towards approval
After 20 years, 2 companies and 1 rejection, FDA approves Marqibo for leukemia
After 20 years in development at two companies, Marqibo vincristine sulfate received accelerated approval from FDAthis month after Talon 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.
Researchers at the University of British Columbia discovered Marqibo, which