ODAC backs Marqibo for ALL

FDA's Oncologic Drugs Advisory Committee voted 7-4, with two abstentions, that Marqibo vincristine from Talon Therapeutics Inc. (OTCBB:TLON) has a favorable benefit-risk profile to treat Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in patients with two or more relapses or in patients whose cancer has progressed following two 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 Monday. ...