FDA Fast Track Designation for Primary Liver Cancer Treatment
News May 19, 2014
BioAlliance Pharma SA today announced that Livatag® (doxorubicin Transdrug™) received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of hepatocellular carcinoma (primary liver cancer) after treatment with Sorafenib.
The Fast Track procedure is designed to facilitate interactions with the FDA and expedite the development time and review period for drugs investigated as treatments for serious or life-threatening diseases with a high unmet medical need.
Primary liver cancer, also called hepatocellular carcinoma, is a particularly aggressive cancer resistant to chemotherapy treatments. It represents the second leading cause of cancer-related deaths worldwide. Few therapeutic alternatives are available and there is a major medical need to improve patients' survival.
Livatag® is a chemotherapy drug using a nanoparticulate formulation. This BioAlliance Pharma's proprietary innovative formulation is designed to overcome the resistance mechanisms developed by tumor cells, mainly responsible for the lack of efficacy of usual chemotherapies. Livatag® is currently in a phase III trial in Europe and in the US as second-line treatment of hepatocellular carcinoma after Sorafenib, at a stage with no available approved treatment.
"This Fast Track designation is a major achievement for the development of Livatag®. It will allow BioAlliance to benefit from frequent and interactive exchanges with the FDA and accelerated review processes. This notably includes, within the product's registration application, the eligibility for priority review meaning a reduced time required for FDA evaluation from 10 to 6 months", comments Judith Greciet, CEO of BioAlliance Pharma. "As of today, more than 25% of patients are enrolled in the ReLive study. With the completion of enrollment planned at the end of 2015 and expected data end of 2016, this development program is the most advanced of our orphan oncology products portfolio, with a drug representing estimated sales potential of nearly €800 million".