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Health Canada Approves BRAFTOVI (Encorafenib) in Combination With Cetuximab, for the Treatment of Patients With Metastatic Colorectal Cancer (mCRC) With a BRAFV600E Mutation


BRAFTOVI plus cetuximab is the first-and-only Health Canada-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAFV600E mutation.

March 31, 2021 – Kirkland, Qc – Pfizer Canada ULC is pleased to announce that Health Canada has approved BRAFTOVI (encorafenib) in combination with cetuximab, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a validated test, after prior therapy.1

In Canada, it is estimated that 26,900 individuals will be diagnosed with colorectal cancer this year. Colorectal cancer is the third most commonly diagnosed cancer in Canada and is the second-leading cause of death from cancer in men and the third-leading cause of death from cancer in women.2 “There is an unmet need for metastatic colorectal cancer patients with BRAFV600e mutations. For these patients, time is of the essence and additional new treatment options such as BRAFTOVI provide an additional opportunity for them to extend their lives”, said Barry D. Stein, President and CEO of Colorectal Cancer Canada.

BRAFTOVI in combination with cetuximab was evaluated in the randomized, active-controlled, open-label, multicenter, Phase 3 BEACON CRC trial. Eligible patients were required to have BRAF V600E mutant metastatic CRC with disease progression after one or two prior regimens. BRAFTOVI is the first and only targeted therapy for metastatic colorectal cancer patients with a BRAF V600E mutation.3

“For our patients in Canada with advanced colorectal cancers that harbour a BRAFV600E mutation, the approval of BRAFTOVI by Health Canada represents a critical advancement in their options for treatment.  This is a challenging disease and BRAFTOVI in combination with cetuximab is proven to meaningfully extend survival, and represents a new standard of care”, said Dr. Sharlene Gill, Medical Oncologist at BC Cancer Agency and Professor in the Department of Medicine at the University of British Columbia.

 “Pfizer is pleased to receive  Health Canada’s approval for  BRAFTOVI in combination with cetuximab for this indication, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” says Cynthia Di Lullo, Oncology Lead, Pfizer Canada ULC. This is a second approval for BRAFTOVI with the approval of BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) at the beginning of March 2021, for patients with a BRAF V600 mutation in metastatic melanoma.

About BRAF-mutant Metastatic Colorectal Cancer

BRAF mutations account for 10% - 15% of metastatic colorectal cancer cases and have a particularly poor prognosis.  BRAFTOVI (encorafenib) in combination with cetuximab is the first and only targeted therapy for mCRC patients with a BRAF mutation who have received prior therapy.4

About BRAFTOVI in Metastatic Colorectal Cancer

BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including colorectal cancer. In Canada, BRAFTOVI (encorafenib) in combination with cetuximab is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAFV600E mutation, as detected by a validated test, after prior therapy.1

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. Drug Product Database Reference for BRAFTOVI Product Monograph

  2. Canadian Cancer Society 2020, Colorectal Cancer Statistics, accessed March 28 2021,

  3. Array BioPharma Inc., Clinical Study Report for ARRAY-818-302. The BEACON CRC Study. A multicenter, randomized, open-label, 3-arm phase 3 study of encorafenib + cetuximab plus or minus binimetinib vs. irinotecan/cetuximab or infusional 5-fluorouracil (5-FU)/folinic acid (FA)/irinotecan (FOLFIRI)/cetuximab with a safety lead-in of encorafenib + binimetinib + cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer. Date: September 12, 2019

  4. Molina-Cerrillo, Javier et al. “BRAF Mutated Colorectal Cancer: New Treatment Approaches.” Cancers vol. 12,6 1571. 14 Jun. 020, doi:10.3390/cancers12061571


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