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Mar 17, 2010

Abraxis Says NSCLC Phase III Trial Met Its Primary Endpoint

  • Abraxis BioScience reports that a Phase III trial showed that Abraxane improved overall response rate in the first-line treatment of patients with advanced non-small-cell lung cancer (NSCLC). The firm says that the FDA previously agreed that this would be sufficient to submit an sNDA for the drug in first-line NSCLC. Abraxis' stock jumped 33% during morning trading.

    “We anticipate filing an sNDA to the FDA during 2011 for what will be the second indication for Abraxane in the U.S,” says Patrick Soon-Shiong, M.D., executive chairman and founder of the firm. The drug is a solvent-free chemotherapy already approved for metastatic breast cancer.

    The randomized Phase III study compared Abraxane to Taxol, both in combination with carboplatin. It completed enrollment of 1,052 patients in July 2009 at 102 sites globally and was led by Mark Socinski, M.D., at the University of North Carolina Lineberger Comprehensive Cancer Center. Significant improvement in overall response rate was the study’s primary endpoint.

    Abraxane was developed using Abraxis’ nab® platform. This protein-bound chemotherapy agent combines paclitaxel with albumin. By wrapping the albumin around the active drug, Abraxane can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel.

    The drug is currently in various stages of investigation to expand applications for metastatic breast cancer as well as to advance into NSCLC, malignant melanoma, pancreatic cancer, and gastric cancer.

    FDA approved Abraxane in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Abraxis reported that the drug brought in $314.5 million in revenue during 2009.

     



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