Abraxane gets CHMP nod for breast cancer

USA-based biopharmaceutical company Abraxis BioScience says that Abraxane (albumin-bound nanoparticle version of paclitaxel) gained a positive approval recommendation from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP). The committee said that the product should be cleared as a treatment for women suffering from metastatic breast cancer who have failed to respond to first-line therapy.

The CHMP's recommendation is based on data from a North American trial in which the drug demonstrated significant superiority, in terms of overall response rate and progression-free survival, to Bristol-Myers Squibb's Taxol (paclitaxel). Abraxis said that it anticipates a final approval decision in the next few months, adding that, if the product is cleared by the EMEA, it will initially be launched in the UK, France, Spain, Italy and Germany.