Roche: Herceptin gains EU breast cancer approval

Roche has announced that Herceptin (trastuzumab) has been granted approval for use in the European Union in combination with an aromatase inhibitor as a treatment for HER2 and hormone receptor co-positive metastatic breast cancer in postmenopausal patients.

This approval follows the publication of the positive results from the phase III Tandem study showing the doubling of median progression-free survival to 4.8 months in patients adding Herceptin to their existing hormonal therapy.

Herceptin, already approved in the EU as a treatment for early and metastatic HER2-positive disease, is a humanised antibody that inhibits the function of that protein produced by a potentially cancer-causing gene.

William M Burns, chief executive officer of Roche Pharmaceuticals, said: “Today’s approval means that for the first time a combination of targeted therapies is available for patients who suffer from a particularly aggressive form of breast cancer.”

He added that the compound was seen to reliably benefit patients irrespective of the stage in progression of the disease at which it is administered and also regardless of its use as a monotherapy or combination treatment with hormonal or chemotherapy.

In November 2006, Roche announced that it would re-inspect vials of Herceptin following reports of cracks in the packaging containing the compound, with the company committed to removing affected products without disrupting supply of the treatment.