- BC is the Third 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, Dec. 6, 2022 /CNW/ - Seagen Canada announced today that TUKYSA (tucatinib) is now covered through BC Cancer. 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
"TUKYSA has demonstrated impressive results in patients with advanced or metastatic HER2-positive breast cancer, including patients whose cancer has spread to the brain, offering an effective treatment option in a population with high unmet need," says Dr. Karen Gelmon, Professor of Medicine, University of British Columbia and Medical Oncologist, BC Cancer. "About half of patients with HER2-positive breast cancer develop brain metastases making the availability of TUKYSA an important addition for this population and physicians when treating this aggressive form of cancer."
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
"Women diagnosed with metastatic HER2-positive breast cancer are faced with the prospect of a shortened life due to this aggressive cancer, robbing them of time with their families, friends and communities" says MJ DeCoteau, Executive Director and Founder of Rethink Breast Cancer. "For too long, these women, particularly those whose cancer has spread to the brain, have had very few treatment options. Now, with the availability of TUKYSA, they have an opportunity for what matters most – more time."
"This announcement is good news for patients in British Columbia with advanced or metastatic HER2-positive breast cancer, some of whom face a dire prognosis," says Cathy Ammendolea, Board Chair, Canadian Breast Cancer Network. "We applaud the provinces who have provided access to TUKYSA already and call on all publicly funded drug programs to reimburse this important therapy for all eligible Canadian patients."
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 pleased that TUKYSA will now be available to eligible patients in British Columbia providing them with a new targeted therapy that has been shown to improve overall survival," says Sandra Heller, General Manager of Seagen Canada. "We are in continuing discussions with other provinces, territories and federal agencies with the goal of securing TUKYSA reimbursement under all publicly funded drug programs."
In addition to BC, TUKYSA is currently reimbursed in Alberta and Quebec.
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 |
SOURCE Seagen
Media Contact: Emma Gilbert, Senior Director, Corporate Communications, Seagen International, +41 76 819 35 83, [email protected]
Share this article