FDA approves Marqibo

FDA granted accelerated approval to an NDA from Talon Therapeutics Inc. (OTCBB:TLON) for Marqibo vincristine 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. Talon plans to launch the nanoparticle liposomal formulation of vincristine in 1Q13. The company said it will disclose the price closer to the launch. The approval is based on data from the open-label Phase II rALLy study in 65 patients which showed a rate of complete response (CR) plus CR with incomplete hematologic recovery of 15%. In March, an FDA panel voted 7-4, with two abstentions, that the drug has a favorable benefit-risk profile (see BioCentury Extra, March 21).

As part of accelerated approval, Talon is required to complete the open-label Phase III HALLMARQ trial to confirm Marqibo's benefit vs. standard vincristine sulfate in 348 newly diagnosed patients. The company began the trial, for which it has an SPA from FDA, in June. Data from the trial are expected in 2016. Talon said it also plans to submit an MAA to EMA for Marqibo next year. Talon was up a penny to $0.98 on Thursday. ...