American health advisors have unanimously rejected the use of the drug Avastin for the treatment of breast cancer.
The decision is a major setback for Roche, the Basel-based manufacturer of the world’s best-selling cancer medicine. Sales of the drug account for about $1 billion (SFr 833 million).
Based on several years of follow-up trials, advisors to the US Food and Drug Administration agreed that Avastin was neither safe nor clinically beneficial. The FDA withdrew its approval of the drug on Wednesday.
“We are very disappointed by the committee’s recommendation and hope the commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options,” said Hal Barron, Roche's chief medical officer and head of global product development.
In a statement released on Thursday, he noted, “We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.”
Some of the side effects include holes in the stomach and intestines plus bleeding and blood clots. However, Roche says that these problems occurred in less than four per cent of patients in the trials.
Avastin is still permitted for breast cancer patients in 80 other countries. European Union health authorities have decided that the drug can be used in combination with chemotherapy agent Xeloda to treat metastatic breast cancer.