Health Canada approves new drug to treat metastatic breast cancer through international and domestic joint reviews

OTTAWA, April 9, 2019 /CNW/ - 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 authorize 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.

In addition to working with the TGA, Health Canada partnered with the Canadian Agency for Drugs and Technologies in Health (CADTH) to align the Department's and the Agency's reviews of Verzenio. CADTH is responsible for making funding recommendations for drug plan coverage to provincial and territorial governments. This partnership reduced the time between Health Canada's approval of the drug and CADTH's recommendation on whether Verzenio should be funded by provincial and territorial governments, resulting in faster access to this new treatment option for Canadians.

Health Canada continues to work to improve the regulatory system for drugs and medical devices to make it even more efficient and predictable.

Quick Facts

• Breast cancer is the most common form of cancer among women worldwide. In 2017, an estimated 26,530 people were diagnosed with breast cancer in Canada.
• Verzenio is a type of drug called a kinase inhibitor. It works by stopping cancer cells from dividing and growing and has been shown to delay the progression of metastatic breast cancer. It provides Canadians who have metastatic breast cancer with another treatment option.
• Verzenio is used alone or in combination with endocrine therapies that are already approved in Canada. When used alone, it is the only drug in its class for use after hormone therapy and chemotherapy have failed. It is an alternative that can be taken orally; other treatment options are limited to additional intravenous chemotherapy.

Associated Links

Notice: Australia Canada Singapore Switzerland (ACSS) Consortium - New Chemical Entities Work Sharing Trial Phase I (April 30, 2018)
Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations (June 22, 2018)

SOURCE Health Canada