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news.France-based BioAlliance Pharma has received Fast Track designation from the US Food and Drug Administration (FDA) for chemotherapy drug Livatag (doxorubicin Transdrug) to treat hepatocellular carcinoma (primary liver cancer) after treatment with Sorafenib.
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Primary liver cancer (hepatocellular carcinoma) is a particularly aggressive cancer resistant to chemotherapy treatments.
Hepatocellular carcinoma represents the second leading cause of cancer-related deaths worldwide and it has few therapeutic alternatives but there is a major medical need to improve patients’ survival.
Livatag uses a nanoparticulate formulation and is designed to overcome the resistance mechanisms developed by tumor cells, mainly responsible for the lack of efficacy of usual chemotherapies.
The drug 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.
BioAlliance Pharma CEO Judith Greciet said the 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," Greciet said.
"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.
"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."