Talon Therapeutics, Inc. announced its New Drug Application (NDA) for Marqibo (vincristine sulfate liposomes injection) was submitted to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of Marqibo in adult Ph- ALL, in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy.
“Submitting the NDA for Marqibo is a pivotal accomplishment for Talon,” stated Steven R. Deitcher MD, President, Chief Executive Officer and Board Member of Talon Therapeutics. “The patient population we are seeking to treat has a grave prognosis comparable to some of the most feared solid tumors such as metastatic pancreatic cancer and gastric cancer, and lacks standard regimens or approved products. Currently available third-line, single-agent therapies induce few responses ( less than or equal to 4%) and are highly toxic. Marqibo’s pivotal study in this advanced and heavily pre-treated population including those requiring 3rd through 7th line therapy and with ECOG performance status of 0-3, resulted in an overall remission rate of 20% with side effects that were predictable and manageable with no unexpected toxicities. We believe there is a significant unmet medical need in this rare hematologic malignancy where Marqibo may provide significant benefit,” Dr. Deitcher concluded.
Date: July 18, 2011
Source: Talon Therapeutics, Inc.
Filed Under: Drug Discovery