- Ontario, Manitoba and Saskatchewan join Alberta, British Columbia and Quebec in Adding TUKYSA to their Provincial Formularies -
- TUKYSA is the First HER-2 Directed Therapy to Significantly Extend Overall Survival in Patients with Metastatic HER2-positive Breast Cancer, who Received One or More Prior Anti-HER2 Therapies in the Metastatic Setting, including Patients with Brain Metastases1,2
MISSISSAUGA, ON, Feb. 22, 2023 /CNW/ - Seagen Canada announced today that TUKYSA (tucatinib) is now reimbursed in Ontario, Manitoba and Saskatchewan. In the HER2CLIMB trial, TUKYSA in combination with trastuzumab and capecitabine significantly improved median overall survival by 4.5 months compared to the placebo combination (21.9 months for the TUKYSA combination group vs. 17.4 months for placebo-combination group).3
TUKYSA is a tyrosine kinase inhibitor indicated in combination with trastuzumab and capecitabine for the treatment of patients with locally advanced unresectable (cannot be surgically removed) or metastatic HER2-positive breast cancer, including patients with brain metastases (disease that has spread to the brain), who have received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine, separately or in combination.4
"Metastatic HER2-positive breast cancer is difficult-to-treat, and about half of these patients develop brain metastases, which significantly limits their treatment options," says Dr. Christine Brezden-Masley, Medical Oncologist and Associate Professor, Temerty Faculty of Medicine, University of Toronto. "TUKYSA has demonstrated a clinically meaningful benefit for these patients, reducing the risk of cancer progression or death, providing a new and effective option for a population with high unmet need."
Breast cancer is the most common cancer in Canadian women.5 In 2022, an estimated 28,600 women will be diagnosed with breast cancer in Canada.6 Approximately 20% of cases are HER2-positive metastatic breast cancer and up to 50% of metastatic HER2-positive breast cancer patients develop brain metastases over time.7,8
"Access to new treatment options can provide hope for women with advanced or metastatic HER2-positive breast cancers, which are typically aggressive and have a higher rate of recurrence," says Cathy Ammendolea, Board Chair, Canadian Breast Cancer Network. "Today's announcement is encouraging news for patients in Ontario, Manitoba and Saskatchewan, and we strongly encourage all remaining provinces to provide equal access to this important therapy."
"Women diagnosed with advanced or metastatic HER2-positive breast cancer are often in the prime of their lives and face the prospect of their time with families, friends and communities being cut short due to this aggressive cancer," says MJ DeCoteau, Executive Director and Founder of Rethink Breast Cancer. "The availability of TUKYSA means these women, especially those with brain metastases who have fewer treatment options, have a chance at more time with the people they love."
Patients with HER2-positive breast cancer have tumours with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. HER2-positive breast cancer is more aggressive and more likely to spread than HER2-negative breast cancer.9 It is also more likely to recur after treatment.10
"We are delighted that eligible patients in Ontario, Manitoba and Saskatchewan now have access to TUKYSA, an innovative treatment option for HER2-positive breast cancer," says Sandra Heller, General Manager of Seagen Canada. "We thank the governments of Ontario, Manitoba and Saskatchewan and are continuing discussions with other provinces, territories and federal agencies to secure TUKYSA formulary listings under all publicly funded drug programs, as we continue to working towards making a meaningful difference in the lives of Canadians impacted by cancer."
In addition to Ontario, Manitoba and Saskatchewan, TUKYSA is currently reimbursed in Alberta, British Columbia and Quebec.
About HER2CLIMB11
The authorization of TUKYSA was based on data from HER2CLIMB, a randomized (2:1), double-blind, placebo-controlled trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine. Forty-eight percent of patients in the study had a presence or history of brain metastases.
Patients who received TUKYSA in combination with trastuzumab and capecitabine had a 46% reduction in the risk of cancer progression or death compared to patients who received trastuzumab and capecitabine alone. The addition of TUKYSA reduced the risk of death by 34%. For patients with brain metastases, the addition of TUKYSA reduced the risk of cancer progression or death by 52% compared to trastuzumab and capecitabine alone.
About TUKYSA (tucatinib)
TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signalling and cell growth (proliferation), and showed anti-tumour activity in HER2-expressing tumour cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumours. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumour activity in vitro and in vivo compared to either medicine alone.
TUKYSA is approved in 38 countries. It was approved by Health Canada on June 5, 2020, by the U.S. FDA in April 2020 and by the European Medicines Agency and the UK Medicines and Healthcare Products Regulatory Agency in February 2021. Merck, known as MSD outside the U.S. and Canada, has exclusive rights to commercialize TUKYSA in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe.
About Seagen
Seagen is a global biotechnology company that discovers, develops, and commercializes transformative cancer medicines to make a meaningful difference in people's lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland, and the European Union. For more information on the company's marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.
_________________________________________________________________________________ 1 TUKYSA® (tucatinib) Canada Product Monograph. July 8, 2021. Available at: https://seagen.ca/assets/pdfs/TUKYSA_Product_Monograph_English.pdf |
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2 Murthy RK, et al. Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2020; 382(7):597-609. |
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3 Ibid. |
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4 TUKYSA® (tucatinib) Canada Product Monograph. July 8, 2021. Available at: https://seagen.ca/assets/pdfs/TUKYSA_Product_Monograph_English.pdf |
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5 Brenner, D.R., et al. Projected estimates of cancer in Canada in 2022. CMAJ May 02, 2022 194 (17) E601-E607. Available at: https://www.cmaj.ca/content/194/17/E601. Accessed on: July 20, 2022. |
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6 Brenner, D.R., et al. Projected estimates of cancer in Canada in 2022. CMAJ May 02, 2022 194 (17) E601-E607. Available at: https://www.cmaj.ca/content/194/17/E601. Accessed on: July 20, 2022. |
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7 Canadian Breast Cancer Network (CBCN). Know your Type Infographic. Available at: https://cbcn.ca/en/know_your_type Accessed on: July 20, 2022. |
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8 Leone, J.P., Lin, N.U. Systemic Therapy of Central Nervous System Metastases of Breast Cancer. Curr Oncol Rep 21, 49 (2019). Available at: https://link.springer.com/article/10.1007/s11912-019-0802-6#citeas. Accessed on: July 20, 2022. |
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9 Canadian Cancer Society. Breast Cancer Statistics. Available at: https://cancer.ca/en/cancer-information/cancer-types/breast/statistics. Accessed on: July 8, 2022. |
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10 Ibid. |
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11 TUKYSA® (tucatinib) Canada Product Monograph. July 8, 2021. Available at: https://seagen.ca/assets/pdfs/TUKYSA_Product_Monograph_English.pdf |
SOURCE Seagen
Media Contact: Emma Gilbert, Senior Director, Corporate Communications, Seagen International, +41 76 819 35 83, [email protected]
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