Clawing towards approval

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...