The U.S. has revoked use of one of the world's best-selling cancer drugs as a treatment for advanced breast cancer.
Government health officials said Friday there is no proof that the use of Avastin extends the lives of patients and that its use may produce dangerous side effects. The commissioner of the U.S. Food and Drug Administration, Margaret Hamburg, said the risks could include severe high blood pressure, massive bleeding, heart attacks and perforations in parts of the body.
The drug agency said the manufacturer's tests on usage of the drug showed only a limited effect on the growth of patients' tumors, and not enough benefit to outweigh the side effects. The drug is made by the Genentech subsidy of the Swiss pharmaceutical Roche. The company voiced disappointment in the ruling, and said it would conduct new tests on the drug. It has produced about $1 billion a year in revenue for the company.
Many breast cancer victims in the U.S. say their lives have been saved by Avastin, a treatment that can cost nearly $100,000 a year. With such testimonials, Hamburg said it was “a difficult decision” to revoke its use. But she said that patients “must have confidence” about the safety and effectiveness of the drugs for their intended use.
The drug can still be prescribed to treat colon, lung, kidney and brain cancers.