Liver Cancer Drug Livatag® Granted U.S. Food and Drug Administration Fast Track Designation
The drug Livatag® (doxorubicin Transdrug™) has received fast-track designation from the U.S. Food and Drug Administration (FDA) for the treatment of primary liver cancer after treatment with Nexavar® (sorafenib). This was recently announced in a press release from BioAlliance Pharma SA, manufacturers of Livatag.
The liver is the largest organ in the body and is responsible for over 500 functions, including the secretion of glucose, proteins, vitamins, and fats; the production of bile; the processing of hemoglobin; and detoxification of numerous substances. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer. According to the Centers for Disease Control and Prevention (CDC), liver cancer is the ninth leading cause of cancer death in the United States and the third leading cause of cancer death worldwide.
Livatag has been developed for the treatment of advanced primary liver cancer. The drug is a formulation of Adriamycin® (doxorubicin), a chemotherapy drug approved by the FDA for the treatment of several cancers, including liver cancer. Livatag uses Transdrug™ technology to deliver Adriamycin; the technology uses nanoparticles (microscopic particles) to penetrate the tumor cell with the drug and increase the cellular exposure to the drug. By using nanoparticles to penetrate the cancer cell, Transdrug technology is designed to treat cancer cells that have become resistant to chemotherapy.
The FDA grants Fast Track status in order to facilitate the development and accelerate the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
Drugs currently approved by the FDA for treatment of advanced liver cancer include Nexavar, which has proven in clinical trials to be superior to other approved treatment. There is currently, however, no available approved treatment after Nexavar; as a result, patients for whom Nexavar is ineffective have no other option.
Researchers in Europe and the United States are currently evaluating Livatag in a Phase III trial for treatment of liver cancer after Nexavar. A representative for BioAlliance Pharma said in the press release that the Fast Track designation is “a major achievement for the development of Livatag.”
 BioAlliance Pharma SA: Livatag® Receives Fast Track Designation From the FDA for the Treatment of Primary Liver Cancer [press release]. BioAlliance Pharma SA. Available at: http://www.fortmilltimes.com/2014/05/19/3489747/bioalliance-pharma-sa-livatag.html
 Cheng A, Kang Y, Lin D, et al. Phase III trial of sunitinib (Su) versus sorafenib (So) in advanced hepatocellular carcinoma (HCC). Results from the 2011 meeting of the American Society of Clinical Oncology (ASCO). July 3-7; Chicago, IL. Abstract #4000.
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