Regulators on opposite sides of the pond have come to different conclusions over the benefits of Roche’s Avastin (bevacizumab) in treating breast cancer.
The European Medicines Agency confirmed the benefits of Avastin in combination with paclitaxel outweighed its risks saying the combination was a valuable treatment option for patients suffering from metastatic breast cancer. However, this was tempered by the Agency’s Committee for Medicinal Products for Human Use conclusion that the drug in combination with docetaxel should no longer be used in the treatment of breast cancer – an indication that had been approved in September 2009 – as new data questioned the combination’s benefits. The Committee also concluded Avastin in combination with capecitabine should not be approved.
While the EMA did announce some positive news for breast cancer patients, the US Food and Drug Administration has come down heavy handed on Roche as it begins the process of removing the breast cancer indication from the drug’s label.
After a review of four clinical studies, the regulator concluded Avastin in combination with paclitaxel neither prolonged overall survival in breast cancer patients nor provided a sufficient benefit in slowing disease progression and did not outweigh the risks associated with the drug.
This decision follows a July review by an independent advisory committee that voted 12-1 to remove the breast cancer indication from the drug’s label. Avastin in combination with paclitaxel was approved for this indication in February 2008 under the FDA’s accelerated approval programme.
However, Roche and manufacturer Genentech are not pleased with the FDA’s ruling and are putting up a fight by not agreeing to remove the breast cancer indication voluntarily. The company now has 15 days to request a hearing, which it has announced it will do.
“We are pleased that the EMA has confirmed the benefits of Avastin in combination with paclitaxel and that Avastin will continue to be available for women with metastatic breast cancer living within the European Union,” said Hal Barron, chief medical officer and head, global product development. “We believe women living in the United States with metastatic HER2-negative breast cancer should also have Avastin as a treatment option, and, therefore, we will request a hearing with the FDA.”
Meanwhile, the FDA is also encouraging Roche to conduct additional research to see if there is a subset of patients who will benefit from the drug.