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 www.astrazeneca.ca.  

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 http://www.daiichi-sankyo.eu.

References

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	^1Canada's Drug Agency - Procedures for Time-Limited Reimbursement Recommendations: Available at: https://www.cda-amc.ca/sites/default/files/Drug_Review_Process/Drug_Reimbursement_Review_Procedures.pdf. Accessed on May 6, 2025.
	^2 pCPA Temporary Access Process (pTAP). Available at:https://www.pcpacanada.ca/pCPATemporaryAccessProcess . Accessed on May 6, 2025.
	^3 ENHERTU^® (trastuzumab deruxtecan), Product Monograph, AstraZeneca Canada Inc., January 17, 2025.
	^4 Van Cutsem E. et al. Trastuzumab deruxtecan in patients in the USA and Europe with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after a trastuzumab-containing regimen (DESTINY-Gastric02): primary and updated analyses from a single-arm, phase 2 study. Lancet Onco^.l 2023; 24: 744–56.
	^5 Shitara, K. et al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020; 382: 2419-30.
	^6 Daiichi Sankyo Co. Ltd. Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04). Available at:  https://clinicaltrials.gov/study/NCT04704934. Accessed on May 6, 2025.
	^7 SEER Cancer Stat Facts: Stomach Cancer. Available at: https://seer.cancer.gov/statfacts/html/stomach.html. Accessed May 6, 2025.
	^8 Sung H et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021; 71(3):209-249.
	^9 Canadian Cancer Society. Stomach Cancer Statistics. Available at: https://cancer.ca/en/cancer-information/cancer-types/stomach/statistics. Accessed on May 6, 2025.

SOURCE AstraZeneca Canada Inc.

Contacts: AstraZeneca: [email protected]; Daiichi Sankyo: Sarah Douglas - [email protected]