The US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has revoked the agency’s approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.
Avastin will remain on the US market as an approved treatment for certain types of colon, lung, kidney and brain cancer.
The drug was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program and remains in Europe.
In September this year, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) approved Avastin in combination with paclitaxel for first-line treatment of patients with metastatic breast cancer.
The EMA remains committed to its decision, but the pressure for a re-evaluation will grow.
“This was a difficult decision,” said Dr Hamburg.
“FDA recognises how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments.
“But patients must have confidence that the drugs they take are both safe and effective for their intended use.
“After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks.
“Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”
Avastin’s risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.
“FDA is committed to working with sponsors to bring promising cancer drugs to market as quickly as possible using tools like accelerated approval,” Dr. Hamburg said.
“I encourage [drug manufacturers] Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug.”