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Health Canada Expands Approval of Pfizer’s LORBRENA as First-Line Treatment for ALK-Positive Metastatic Lung Cancer


Kirkland, QC, June 7, 2021 – Health Canada has granted Pfizer Canada a Notice of Compliance (NOC) for LORBRENA (lorlatinib) to be used as monotherapy in the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). The application was approved in an accelerated timeframe by Health Canada through the FDA’s Project Orbis, which allowed for concurrent submission and review of oncology products between the FDA and international partners including Health Canada.1 

Lung cancer has traditionally been one of the most difficult cancers to treat, because symptoms typically do not appear until the disease has already reached an advanced stage.  Even when symptoms appear, they are often mistaken for other health problems, further delaying patients from receiving the care they may need.2

“A decade ago, there were only a limited number of options for patients with non-small cell lung cancer,” said Dr. Geoffrey Liu, Medical Oncologist at the Princess Margret Cancer Centre in Toronto. “Today, however, due to major advances, the treatment landscape has changed and LORBRENA’s new indication is an important new option for people with a specific subtype of non-small cell lung cancer.”

“Health Canada’s approval for LORBRENA to be used as monotherapy in the first-line treatment of adult patients with ALK-positive metastatic non-small cell lung cancer demonstrates Pfizer’s commitment to advancing treatment options for patients,” says Cynthia Di Lullo, Oncology Lead, Pfizer Canada ULC.

In 2019, LORBRENA (lorlatinib) was granted a Notice of Compliance with conditions (NOC/c) to be used as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib.

About Non-Small Cell Lung Cancer (NSCLC)  

It is estimated that in 2020, 29,800 Canadians were diagnosed with lung cancer. This represents 13% of all new cancer cases in 2020. It is estimated that 21,200 Canadians died from lung cancer in 2020, representing 25% of all cancer deaths. As a percentage of all cancer deaths, lung cancers kill more Canadians than breast cancer, colorectal cancer and prostate cancer combined.3

“New options such as LORBRENA provide more choices for lung cancer patients and their families,” says Shem Singh, Executive Director at Lung Cancer Canada. “Innovation and choice are key to improving survival rates for people living with lung cancer.”

LORBRENA is a third-generation ALK inhibitor specifically designed to inhibit the most common tumor mutations that drive resistance to current medications and to address metastases in the brain, a frequent site for disease progression in ALK-positive metastatic NSCLC.   

About Pfizer Canada

Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified healthcare portfolio includes some of the world's best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit or you can follow us on LinkedInFacebookTwitter or YouTube.

For further information:

Corporate Affairs Canada
1-866-9PFIZER (1-866-973-4937)

[email protected]

  1. Lorbrena Product Monograph, June 4, 2021.

  2. Canadian Lung Association, Signs and symptoms (2021). Available at  Accessed online May 6 2021

  3. Cancer Canada, Signs and symptoms of lung cancer. 2021. Available at  Accessed on line April 30, 2021.


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