European panel rejects use of bevacizumab (Avastin®) for metastatic breast cancer

July 9, 2010

The National Institute of Health and Clinical Excellence (NICE), a panel that establishes guidelines for the National Health Service in England and Wales, has issued a draft guidance recommending against the use of bevacizumab (Avastin®) in combination with a taxane for patients whose breast cancer has spread to other parts of the body.  Evidence submitted to NICE by the drug manufacturer did not show bevacizumab to significantly improve or extend the lives of metastatic breast cancer patients, according to a report from Medical News Today.

The drug manufacturer submitted data from a clinical trial comparing bevacizumab plus paclitaxel with paclitaxel alone.  The study found that bevacizumab slowed the growth and spread of the cancer, but that this did not translate to improvements in overall survival. 

The Medical News Today report quotes NICE Chief Executive Sir Andrew Dillon,  "The clinical trial results for bevacizumab were disappointing in that they were unable to prove definitively that the drug could extend the lives of patients with metastatic breast cancer over and above currently available treatments. The Committee did hear evidence from a clinical expert and patient representative that the amount of time a drug can slow the growth and spread of the cancer is highly valued by patients but evidence of the length of time bevacizumab could keep the cancer under control was not robust. There was also no proof that the drug can give patients a better quality of life than paclitaxel or docetaxel."

In a controversial decision, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bevacizumab in combination with paclitaxel in 2008.  An advisory committee to the FDA will be considering granting general approval for the use, as well as approval of use with other chemotherapy agents, on July 20.