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news.Abraxis BioScience has said the European Medicines Agency has accepted for review the company's application for Abraxane for injectable suspension in the treatment of breast cancer.
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The typical EMEA review period for this centralized procedure is approximately 12 months.
In conjunction with this filing, the company has also announced its intent to seek a global commercialization partner for Abraxane.
The European submission is based on a phase III comparative study of women with metastatic breast cancer conducted by the company. This randomized trial compared Abraxane given as a 30-minute infusion without pre-medication versus solvent-based paclitaxel injection Taxol given as a 3-hour infusion with standard steroid and antihistamine pre-medication.
As reported in the European submission, patients in the Abraxane treatment arm had a superior investigator overall response rate of 33.2%, compared to 18.7% for patients in the paclitaxel injection treatment arm
Abraxane is the first in a new class of protein-bound taxanes that takes advantage of albumin, a human protein and natural carrier of water insoluble molecules. The use of albumin eliminates the need for solvents and the associated toxicities with solvent-based paclitaxel chemotherapy.
Abraxane has already received approval from the FDA and Health Canada.