Joining FDA, Canada pulls Avastin's breast cancer indication

Ten days after the FDA decided to pull the breast cancer indication off Avastin's label, Health Canada is doing the same. The Canadian regulator has asked Roche to erase that use from Avastin's list. The change may not make much difference in the drug's Canadian sales, however, The Globe and Mail reports, because most provincial governments don't pay for it anyway.

The Canadian agency conducted its own review of the Avastin evidence, including clinical trial data from Roche, the FDA and the European Medicines Agency. After that review--and input from an independent committee of medical experts and patient advocates--the agency determined that the potential harm of using the drug in metastatic breast cancer outweighed its potential benefits.

"Health Canada has concluded that Avastin does not significantly reduce tumour size or extend lives, while it may cause serious and potentially life-threatening risks," the agency said in a statement, adding that its expert committee determined, "[B]ased on the current available evidence, there is no value in maintaining Avastin as a treatment option."

Suspending the breast cancer indication has no effect on Avastin's other approvals, in colorectal cancer, lung cancer and a particular type of brain cancer.

- see the statement from Health Canada
- get more from The Globe and Mail
- read the CBC story

Suggested Articles

Look out, diabetes market: Novo Nordisk won its FDA nod for highly anticipated Rybelsus to control blood sugar in patients with Type 2 diabetes.

Insys is in fire sale mode as part of its bankruptcy plan, and now it’s been given the go-ahead to sell the opioid that helped get it there.

GSK CEO Emma Walmsley could soon have a new title: Microsoft board member. The software giant has nominated her to its board of directors.