Posted by Michael Wonder on 09 Apr 2019
Health Canada approves new drug to treat metastatic breast cancer through international and domestic joint reviews
9 April 2019 - Canadians want improved access to the most recent and innovative treatment options for themselves and their families.
To help bring new treatments to Canada, Health Canada is partnering with other international regulators to jointly review and authorise new drugs. These partnerships decrease the time it takes to get new treatments to the people who need them and reduce the cost of the drug review process.
Following a joint review with Australia's Therapeutic Goods Administration (TGA), Health Canada approved Verzenio (abemaciclib) for the treatment of metastatic breast cancer. Verzenio is the first drug to be reviewed collaboratively both internationally and domestically. It is also only the second drug that Health Canada has jointly reviewed with the TGA, which was an opportunity to further solidify strong international partnerships among like-minded international regulators.
The review of this drug was conducted under the Australia Canada Singapore Switzerland Consortium's New Chemical Entities Work Sharing Initiative. These partnerships bring together countries with smaller markets to create a larger population base, which may make it more attractive for a drug company to file a submission to sell its drug in Canada.
