MISSISSAUGA, ON, Sept. 29, 2022 /CNW/ - Seagen Canada has entered into a Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding TUKYSA, 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.1
"Concluding negotiations with the pCPA is an important step in our efforts to secure public funding of TUKYSA for appropriate patients across Canada," says Sandra Heller, General Manager of Seagen Canada. "We thank the pCPA for their efforts, and we look forward to working with the provinces, territories, and federal agencies to make TUKYSA available to those living with HER2-positive metastatic breast cancer."
"This milestone signifies important progress for Canadians battling HER2-positive metastatic breast cancer," says Cathy Ammendolea, Board Chair, Canadian Breast Cancer Network. "Access to new and effective treatment options is extremely important for patients with this aggressive form of breast cancer, and we hope that the provinces and territories will move quickly to add this therapy to their public formularies."
"Having more time is a priority for people with metastatic breast cancer, which is closely linked to having access to treatments that can improve survival," said MJ DeCoteau, Founder and Executive Director of Rethink Breast Cancer. "There is a lot of anticipation in the breast cancer community for TUKYSA – especially a new treatment that included patients with brain metastases – but for it to truly be impactful for Canadian patients, we need to ensure they can access it without uncertainty or delay."
With the Letter of Intent with the pCPA now in place, Seagen Canada will be entering into discussions with participating provinces, territories and federal agencies regarding reimbursement of TUKYSA under publicly funded drug programs.
About HER2-Positive Breast Cancer
Breast cancer is the most common cancer in Canadian women with approximately 20% of cases per year being aggressive HER2-positive metastatic breast cancer.2 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. Up to 50% of metastatic HER2-positive breast cancer patients develop brain metastases over time.3 In 2022, an estimated 28,600 Canadian women will be diagnosed with breast cancer.4
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.
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
2 Canadian Breast Cancer Network (CBCN). Know your Type Infographic. Available at: https://cbcn.ca/en/know_your_type Accessed on: July 20, 2022.
3 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.
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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