Alberta is the First Province to Add TUKYSA to its Provincial Formulary
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, Oct. 20, 2022 /CNW/ - Seagen Canada announced today that TUKYSA (tucatinib) is now reimbursed through the Alberta Health Services Outpatient Cancer Drug Benefit Program. 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).
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.3
"Advanced and metastatic HER2-positive breast cancers are a challenge to treat. Currently, there are limited treatment options for patients whose cancer has spread to the brain," says Dr. Nancy Nixon, Medical Oncologist, Alberta Health Services. "The availability of TUKYSA provides physicians and patients in Alberta with an important new treatment option that has demonstrated a clinically meaningful benefit, reducing the risk of cancer progression or death, including in patients with brain metastases."
Breast cancer is the most common cancer in Canadian women.4 In 2022, an estimated 28,600 women will be diagnosed with breast cancer in Canada5. 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.6,7
"Over many years of working closely with young women with metastatic breast cancer, they want to live as long as they can with a good quality of life – they want to see their children grow, have more life experiences and contribute to their communities. To make this a reality, they need timely access to effective treatments, like TUKYSA, that can keep their disease under control so they can go on to living well, longer," said MJ DeCoteau, Founder and Executive Director, Rethink Breast Cancer.
"Today's announcement is encouraging news for HER2-positive breast cancer patients with advanced disease, who often face a difficult prognosis," says Cathy Ammendolea, Board Chair, Canadian Breast Cancer Network. "We applaud the Government of Alberta and hope that other provinces and territories follow their lead to provide equal access to all Canadian patients who could benefit from this therapy."
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.8 It is also more likely to recur after treatment.9
"The inclusion of TUKYSA on the Alberta public formulary allows patients in the province to now have access to an effective new treatment option to fight this aggressive cancer," says Sandra Heller, General Manager of Seagen Canada. "We thank the Government of Alberta for their leadership in being the first province to reimburse TUKYSA for eligible patients."
Seagen Canada is continuing discussions with other provinces, territories, and federal agencies regarding the reimbursement of TUKYSA under publicly funded drug programs.
The authorization of TUKYA 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.
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.
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 TUKYSA™ (tucatinib) Canada Product Monograph. July 8, 2021. Available at: https://seagen.ca/assets/pdfs/TUKYSA_Product_Monograph_English.pdf |
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4 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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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 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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7 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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8 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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9 Ibid. |
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10 TUKYSA® (tucatinib) Canada Product Monograph. July 8, 2021. Available at: https://seagen.ca/assets/pdfs/TUKYSA_Product_Monograph_English.pdf |
SOURCE Seagen
Emma Gilbert, Senior Director, Corporate Communications, Seagen International, +41 76 819 35 83, [email protected]
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