Marqibo vincristine regulatory update

FDA's Oncologic Drugs Advisory Committee voted 7-4, with 2 abstentions, that Talon's Marqibo vincristine has a favorable benefit-risk profile to treat Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in patients with 2 or more relapses or in patients whose cancer has progressed following 2 or more leukemia therapies. The NDA has a May 13 PDUFA date. Talon is seeking accelerated approval based on data from the open-label Phase II rALLy study in 65 patients, which FDA said showed a complete response (CR) rate of 5% and a rate of CR/CR with incomplete hematologic recovery of 15%, according to briefing documents posted March 19. ...