May 7, 2012 Talon Therapeutics Receives Notification of Three Month PDUFA Date Extension for Marqibo(R) SAN MATEO, Calif., May 7, 2012 (GLOBE NEWSWIRE) -- Talon Therapeutics Inc., (OTCBB:TLON), today announced that it has been informed by the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) seeking accelerated approval of Marqibo® has been given a three-month Prescription Drug User Fee Act (PDUFA) date extension to August 12, 2012.
On March 21, 2012, the Oncologic Drugs Advisory Committee (ODAC) voted 7 to 4, with 2 abstentions, that evidence from clinical studies supports a favorable benefit/risk assessment for use of Marqibo(R) in the treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy. The FDA has requested additional information unrelated to clinical trials regarding Marqibo. Talon has submitted responses to all outstanding requests. The FDA has informed Talon that in order to complete its review of the submitted information, the FDA has extended the Marqibo PDUFA date for 3 months.
"We will continue to work collaboratively with the FDA during this review process and will continue on-going label negotiations," stated Steven R. Deitcher MD, President, Chief Executive Officer and Board Member of Talon Therapeutics. "In addition, we will continue to conduct our Phase 3 confirmatory trial, which received Special Protocol Assessment agreement from the FDA, in front-line adult elderly ALL," Dr. Deitcher added.
About Marqibo® (vincristine sulfate liposome injection) Marqibo is a novel, targeted Optisome™ encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon is primarily developing Marqibo for the treatment of Ph- adult ALL. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphomas and leukemias. Talon's encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner. Talon has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the FDA. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.
In addition to the Phase 3 confirmatory study of Marqibo in front-line adult elderly ALL, Marqibo is being evaluated in an on-going Phase 3 trial in front-line adult elderly aggressive non-Hodgkin's lymphoma conducted by the German High Grade Non-Hodgkin's Lymphoma Study group, and in a Phase 1 trial in pediatric cancers, including ALL, being conducted by the National Cancer Institute. A phase 2 trial of Marqibo in front-line adult ALL to be conducted by the M.D. Anderson Cancer Center is expected to begin enrolling in the third quarter of 2012.
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