Latest news with #GabyBourbara
Associated Press
23-05-2025
- Business
- Associated Press
ENHERTU® (trastuzumab deruxtecan) Receives Time-Limited Reimbursement Recommendation from Canada's Drug Agency for Gastric Cancer
MISSISSAUGA, ON, May 23, 2025 /CNW/ - AstraZeneca (AZ) and Daiichi Sankyo (DS) are pleased to announce that Canada's Drug Agency (CDA, formerly CADTH) has issued a Time-Limited Reimbursement (TLR) recommendation – the first in gastric cancer – for ENHERTU® (trastuzumab deruxtecan) based on the unmet need of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Additionally, the pan-Canadian Pharmaceutical Alliance (pCPA), AstraZeneca, and Daiichi Sankyo have recently signed a Letter of Intent (LOI) through the recently introduced Temporary Access Process (pTAP). This step, alongside the CDA TLR processes, paves the way for jurisdictional reimbursement. 'As early participants in these innovative drug reimbursement processes, AstraZeneca and Daiichi Sankyo are pleased to accelerate access to innovative treatments for Canadian patients, particularly in areas of great unmet need, such as HER2+ gastric cancer,' says Gaby Bourbara, President, AstraZeneca Canada. 'The TLR/pTAP process is intended for a subset of medicines assessed with a very specific set of criteria, and we look forward to continuing to work with our partners within the drug reimbursement ecosystem to unlock additional mechanisms for accelerating access to more medicines in the future.' It is estimated that these processes will make ENHERTU available to gastric cancer patients close to two years faster than traditional reimbursement pathways which would have required the completion and review of the Phase III DESTINY-Gastric04 study. 'Daiichi Sankyo and our partners at AstraZeneca are committed to ongoing collaboration with the HTA bodies to identify and leverage new ways to make medicines accessible to patients across the country as fast as possible following Health Canada approval,' says Fatih Yedikardeş, Country Manager, Daiichi Sankyo Canada. For medications that show early promise and have been given conditional regulatory approval, the TLR and pTAP processes represent a path for accelerated access while ongoing confirmatory trials are in progress.1,2 Health Canada granted a Notice of Compliance with conditions (NOC/c) for ENHERTU (trastuzumab deruxtecan) on January 17, 2025, for the treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.3 The conditional approval was authorized based on results from DESTINY-Gastric024 and DESTINY-Gastric015 Phase II trials. The confirmatory Phase III trial, DESTINY-Gastric046 is currently underway and is a global, randomized, open-label, trial evaluating the efficacy and safety of trastuzumab deruxtecan (6.4 mg/kg) versus ramucirumab and paclitaxel in patients with HER2- positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen. About Gastric Cancer Gastric (stomach) cancer is the fifth most common cancer worldwide and the fourth leading cause of cancer mortality with a five-year survival rate of 7.5% for metastatic disease.7,8 In Canada, it is estimated that 4,200 people will be diagnosed, and 2,000 people will die from the disease this year.9 About ENHERTU ENHERTU (trastuzumab deruxtecan) is a HER2-directed antibody-drug conjugate. Designed using Daiichi Sankyo's proprietary DXd antibody drug conjugate (ADC) technology, ENHERTU consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan (Dato-DXd) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical business whose innovative medicines are used by millions of patients worldwide. The company's core areas of scientific focus are Oncology; Cardiovascular, Renal and Metabolic (CVRM); Rare Disease; Respiratory & Immunology; and Vaccine & Immune Therapies. In Canada, the company employs more than 2,400 people and recently announced a major expansion of its research footprint in Mississauga – including the expansion of its AstraZeneca R&D Hub and the creation of a new Alexion Development Hub for Rare Diseases. AstraZeneca was recently recognized as one of Canada's Top 100 Employers, one of Canada's Most Admired Corporate Cultures, and a Greater Toronto Top Employer. AstraZeneca is committed to contributing to a more sustainable future for people, society and planet, taking important steps to help tackle some of the most pressing sustainability challenges globally – from climate and biodiversity loss, to health equity and health system resilience. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. For more information, please visit the company's website at About Daiichi Sankyo Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose 'to contribute to the enrichment of quality of life around the world.' In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an 'Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.' For more information, please visit References SOURCE AstraZeneca Canada Inc.
Cision Canada
23-05-2025
- Business
- Cision Canada
ENHERTU® (trastuzumab deruxtecan) Receives Time-Limited Reimbursement Recommendation from Canada's Drug Agency for Gastric Cancer Français
MISSISSAUGA, ON, May 23, 2025 /CNW/ - AstraZeneca (AZ) and Daiichi Sankyo (DS) are pleased to announce that Canada's Drug Agency (CDA, formerly CADTH) has issued a Time-Limited Reimbursement (TLR) recommendation – the first in gastric cancer – for ENHERTU ® (trastuzumab deruxtecan) based on the unmet need of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Additionally, the pan-Canadian Pharmaceutical Alliance (pCPA), AstraZeneca, and Daiichi Sankyo have recently signed a Letter of Intent (LOI) through the recently introduced Temporary Access Process (pTAP). This step, alongside the CDA TLR processes, paves the way for jurisdictional reimbursement. "As early participants in these innovative drug reimbursement processes, AstraZeneca and Daiichi Sankyo are pleased to accelerate access to innovative treatments for Canadian patients, particularly in areas of great unmet need, such as HER2+ gastric cancer," says Gaby Bourbara, President, AstraZeneca Canada. "The TLR/pTAP process is intended for a subset of medicines assessed with a very specific set of criteria, and we look forward to continuing to work with our partners within the drug reimbursement ecosystem to unlock additional mechanisms for accelerating access to more medicines in the future." It is estimated that these processes will make ENHERTU available to gastric cancer patients close to two years faster than traditional reimbursement pathways which would have required the completion and review of the Phase III DESTINY-Gastric04 study. "Daiichi Sankyo and our partners at AstraZeneca are committed to ongoing collaboration with the HTA bodies to identify and leverage new ways to make medicines accessible to patients across the country as fast as possible following Health Canada approval," says Fatih Yedikardeş, Country Manager, Daiichi Sankyo Canada. For medications that show early promise and have been given conditional regulatory approval, the TLR and pTAP processes represent a path for accelerated access while ongoing confirmatory trials are in progress. 1,2 Health Canada granted a Notice of Compliance with conditions (NOC/c) for ENHERTU (trastuzumab deruxtecan) on January 17, 2025, for the treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. 3 The conditional approval was authorized based on results from DESTINY-Gastric02 4 and DESTINY-Gastric01 5 Phase II trials. The confirmatory Phase III trial, DESTINY-Gastric04 6 is currently underway and is a global, randomized, open-label, trial evaluating the efficacy and safety of trastuzumab deruxtecan (6.4 mg/kg) versus ramucirumab and paclitaxel in patients with HER2- positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen. About Gastric Cancer Gastric (stomach) cancer is the fifth most common cancer worldwide and the fourth leading cause of cancer mortality with a five-year survival rate of 7.5% for metastatic disease. 7,8 In Canada, it is estimated that 4,200 people will be diagnosed, and 2,000 people will die from the disease this year. 9 About ENHERTU ENHERTU (trastuzumab deruxtecan) is a HER2-directed antibody-drug conjugate. Designed using Daiichi Sankyo's proprietary DXd antibody drug conjugate (ADC) technology, ENHERTU consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan (Dato-DXd) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical business whose innovative medicines are used by millions of patients worldwide. The company's core areas of scientific focus are Oncology; Cardiovascular, Renal and Metabolic (CVRM); Rare Disease; Respiratory & Immunology; and Vaccine & Immune Therapies. In Canada, the company employs more than 2,400 people and recently announced a major expansion of its research footprint in Mississauga – including the expansion of its AstraZeneca R&D Hub and the creation of a new Alexion Development Hub for Rare Diseases. AstraZeneca was recently recognized as one of Canada's Top 100 Employers, one of Canada's Most Admired Corporate Cultures, and a Greater Toronto Top Employer. AstraZeneca is committed to contributing to a more sustainable future for people, society and planet, taking important steps to help tackle some of the most pressing sustainability challenges globally – from climate and biodiversity loss, to health equity and health system resilience. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. For more information, please visit the company's website at About Daiichi Sankyo Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society." For more information, please visit
Cision Canada
06-05-2025
- Business
- Cision Canada
AstraZeneca Canada and Plan International Canada Seek Next Generation of Sustainability Leaders for 2025-2026 Eureka Fellowship for Youth Changemakers in Canada Français
Applications are now open for the 2025-26 Eureka Fellowship, which will support the impact of young sustainability leaders through learning opportunities and funding TORONTO, May 6, 2025 /CNW/ - AstraZeneca Canada and Plan International Canada are launching the 2025-26 Eureka Fellowship for Youth Changemakers in Canada (Eureka Fellowship). Now in its second year, the Eureka Fellowship aims to identify, accelerate and amplify the impact of the next generation of sustainability leaders working to improve the health of people, society and the planet. "At AstraZeneca, we are committed to driving positive change beyond the impact of our medicines and we share Plan International Canada's belief in the power of individuals to make a big difference," says Gaby Bourbara, President, AstraZeneca Canada. "Last year we saw the incredible impact of Eureka Fellows in reducing gender inequity in healthcare, addressing climate change in Canada's North, tackling biodiversity loss, and advocating for health equity in Indigenous communities, to name just a few examples. We look forward to supporting a new group of Eureka Fellows who are focused on building a healthier, more equitable world." "The 2024 Eureka Fellows tackled some of our most urgent challenges with spirit and determination," says Lindsay Glassco, President and CEO, Plan International Canada. "Eureka Fellows don't just imagine a better world; they roll up their sleeves and start building it! And we are proud to once again join AstraZeneca Canada in championing a new cohort of changemakers who are leading the way in shaping a more sustainable and equitable future for all." Applications are now open for the 2025-26 Eureka Fellowship. Successful applicants will need to present a sustainability initiative that is delivering clear impact – via a registered charitable organization or through a self-initiated community project – to improve the health of people, society and/or the planet, with a particular focus on health equity, health system resilience, biodiversity and climate action. This opportunity is available to Canadian residents who are aged 18 to 30, as of December 31, 2025. A total of 10 Eureka Fellows will be selected to participate in the 18-month program, which will conclude in December 2026. The Eureka Fellowship will support youth sustainability leaders by: Driving impact with $10,000 in funding towards each Eureka Fellow's registered charitable organization or community project. Supporting learning and leadership development through a virtual curriculum and workshops. Building broader awareness and connections via networking opportunities and an in-person Summit in 2026, while also helping Eureka Fellows build their profile. Creating community with an invitation to join the Eureka Fellowship Alumni Network. "I came to this country as an immigrant not knowing how to navigate the Canadian health care system. I lived in a remote community, and I've seen firsthand how marginalized communities, including immigrants and Indigenous peoples, face barriers to access health care," says Inaam Chattha, one of the 2024 Eureka Fellows. "Being a young advocate, I hope to ensure that every Canadian has access to equitable health care that works for them. The Eureka Fellowship has helped me accelerate my efforts." To apply for the 2025-26 Eureka Fellowship for Youth Changemakers in Canada, please visit The deadline to apply is June 8 and successful applicants will be notified this summer. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. In Canada, the company employs more than 2,300 people and was recently named one of Canada's Top 100 Employers for the second consecutive year. Together, AstraZeneca's R&D Hub and the Alexion, AstraZeneca Rare Disease Development Hub – both based in Mississauga, Ontario – are leading more than 210 global clinical studies in areas such as breast, lung and prostate cancer, COPD, chronic kidney disease, and rare disease. Visit for more information. About Plan International Canada Plan International Canada is a member of a global organization dedicated to advancing children's rights and equality for girls. Plan International has been building powerful partnerships for children for over 85 years and is now active in more than 80 countries. We stand with children, especially girls, wherever they are oppressed, exploited, left behind or not equally valued. We're determined optimists and will continue to persevere until we are all equal. Visit for more information. About Eureka Fellowship The Eureka Fellowship for Youth Changemakers in Canada (Eureka Fellowship) aims to identify, accelerate and amplify the impact of the next generation of sustainability leaders working to improve the health of people, society and the planet. Created in 2024 by AstraZeneca Canada and Plan International Canada, the Eureka Fellowship has supported youth sustainability leaders in communities across Canada. To learn more, visit SOURCE AstraZeneca Canada Inc.
