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HEALTH CANADA APPROVES BRAFTOVI AND MEKTOVI FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600 MUTATION

02/03/21

Melanoma is one of the most aggressive and deadly forms of skin cancer. The lifetime probability of developing melanoma in Canada is 1 in 42 for males and 1 in 56 for females.

March 2, 2021 – Kirkland, Qc – Pfizer Canada ULC announced that Health Canada has approved BRAFTOVI (encorafenib) to be used in combination with MEKTOVI (binimetinib), for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test. In Canada, it is estimated that 8,000 Canadians were diagnosed with melanoma skin cancer in 2020 (i.e., 4,400 males and 3,600 females). Melanoma is the eighth leading cause of all new cancer cases in Canada, and is estimated to account for 3.5% of the total new cancer cases in Canada in 2020.11-2

Melanoma is one of the most aggressive and deadly forms of skin cancer. The lifetime probability of developing melanoma in Canada is 1 in 42 for males and 1 in 56 for females.

“Combined BRAFTOVI plus MEKTOVI provides a new therapeutic alternative to current targeted therapies for unresectable or metastatic BRAF V600 mutation positive melanoma,” said Dr. Wilson, Director of the Clinical Research Program at the Jewish General Hospital, and Professor at the Departments of Oncology and Medicine at McGill University.

“We are excited to see novel ways to treat advanced melanoma,” said Kathy Barnard, a melanoma survivor and founder of the Save Your Skin Foundation. “Patients living with melanoma need options, and having new targeted therapies approved ensures that there are more tools available to fight the battle against skin cancer.”

BRAFTOVI and MEKTOVI used in combination has been granted a notice of compliance (NOC) based on data from the COLUMBUS study.3 The COLUMBUS trial is a two-part, international, randomized, open label Phase 3 trial evaluating the efficacy and safety of BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) compared to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAFV600 mutation.4

“Pfizer Canada is proud to bring this new targeted therapy to Canadians, demonstrating our commitment to providing innovative cancer treatment options to patients in need,” says Cynthia Di Lullo, Oncology Lead, Pfizer Canada ULC.

 

About BRAF-mutant Metastatic Melanoma

Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates.5 There are a variety of gene mutations that can lead to metastatic melanoma. The most common somatic genetic variants in metastatic melanoma are mutations in the BRAF gene.6

 

About BRAFTOVI and MEKTOVI

BRAFTOVI is an oral small molecule BRAF kinase inhibitor and MEKTOVI is an oral small molecule MEK inhibitor which target key enzymes in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma, colorectal cancer, non-small cell lung cancer and others. In Canada, BRAFTOVI plus MEKTOVI are approved for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.3

 

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 pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube.

 

For further information:

Corporate Affairs Canada
1-866-9PFIZER (1-866-973-4937)
[email protected]

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  1. Ryu S, Youn C, Moon A, et al. Therapeutic inhibitors against mutated BRAF and MEK for the treatment of metastatic melanoma. Chonnam Med J 2017;53:173-7.
  2. Miller A, Mihm M. Melanoma. N Engl J Med 2006;355:51-65.
  3. Drug Product Database Reference for BRAFTOVI AND MEKTOVI Product Monographs
  4. Dummer R, Ascierto PA, Gogas HJ, Arance A, Mandala M, Liszkay G, Garbe C, Schadendorf D, Krajsova I, Gutzmer R, Chiarion Sileni V, Dutriaux C, de Groot JWB, Yamazaki N, Loquai C, Moutouh-de Parseval LA, Pickard MD, Sandor V, Robert C, Flaherty KT, Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial.. Lancet Oncol. 2018 Oct;19(10):1315-1327. doi: 10.1016/S1470-2045(18)30497-2.
  5. Ascierto P, Kirkwood J,Grob J, Simeone E, Grimaldi A, Maio M, Palmieri G, Testori A, Marincola F, Mozzillo N, The role of BRAF V600 mutation in melanoma, J Transl Med2012 Jul 9;10:85. doi: 10.1186/1479-5876-10-85
  6. Brenner D, Weir H, Demers A, Ellison L, Louzado C, Shaw A, Turner D, Woods R, Smith L, Projected estimates of cancer in Canada in 2020; for the Canadian Cancer Statistics Advisory Committee, CMAJ 2020 March 2;192:E199-205. doi: 10.1503/cmaj.191292