Roche announced that European regulators have

started a review of the benefits and risks of Avastin for the treatment of breast cancer after the company submitted new clinical trial data as part of a regulatory application seeking to expand the drug's label. Helvea analyst, Karl Heinz Koch, commented that "the EU review is certainly bad news," adding that "the review could potentially mean that Avastin could be pulled from the market for the treatment of metastatic breast cancer. In the current environment, everything is possible."

Avastin is currently approved in the EU as a first-line treatment for patients with metastatic breast cancer in combination with paclitaxel or sanofi-aventis’ Taxotere (docetaxel). Roche is seeking to expand approval of the drug to include treatment in combination with an anthracycline or Xeloda (capecitabine), based on data from the RIBBON-1 trial. However, the EMA noted that "in comparison to results of previous studies, this study points to inconsistencies between different trials…particularly in terms of efficacy."

The Swiss drugmaker said it would work with the EMA's Committee for Medicinal Products for Human Use, which is conducting the review, adding that the decision on whether to expand approval of Avastin is expected later this year.

In the US, the FDA recently delayed a decision on whether to allow Roche to continue marketing Avastin as a first-line treatment for certain patients with breast cancer after the company submitted additional information. A decision is due from the agency by December 17