MARKHAM, ON, Oct. 1, 2025 /CNW/ - Astellas Pharma Canada Inc. is proud to announce that VYLOY® (zolbetuximab) is now funded by the Ontario Drug Benefit Program under the New Drug Funding Program and in Quebec through the Liste des médicaments - Établissements de la RAMQ. VYLOY is funded as a first-line treatment for adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive as determined by a validated test in both provinces.
Health Canada granted Astellas market authorization of VYLOY in December 2024. The decision to reimburse VYLOY in Quebec and Ontario is a milestone towards making this important therapy available to patients.
Dr. Christine Brezden-Masley, Medical Oncologist, Mount Sinai Hospital
"Advanced gastric cancer is associated with a high mortality and historically patients have had limited treatment options. The timely public reimbursement of this targeted treatment is welcomed as treatment with VYLOY has been shown in clinical studies to significantly extend both progression-free survival and overall survival. Reducing barriers to access VYLOY allows patients access to this critically important and effective targeted treatment option for CLDN18.2 positive advanced gastric cancer patients."
Sandra Heller, General Manager, Astellas Pharma Canada
"Astellas is proud to bring another innovative medicine for personalized oncology care to Canadians and we applaud these provincial decisions to publicly reimburse VYLOY. This latest milestone highlights our commitment to patients having access to the therapies they require for better health outcomes. At Astellas, we remain dedicated to supporting the transformation of how physicians can treat advanced cancers, providing them with innovative options and giving greater hope to patients."
Teresa Tiano, Chair & Co-Founder, My Gut Feeling
"My Gut Feeling is deeply committed to supporting Canadian patients with stomach cancer and strongly advocates for investment in research, development and advocacy to offer patients hope. Innovations in personalized medicine, such as zolbetuximab, are ushering in a new era for the treatment and management of cancers like stomach cancer. The more patients are able to access these treatments as a result of provincial listings such as these, the better served our community will be."
Reimbursement Criteria
Specific reimbursement criteria must be met for public coverage of VYLOY. Complete information can be found by consulting the respective provincial formularies.
About VYLOY (Zolbetuximab)
Zolbetuximab is a claudin 18.2-directed cytolytic antibody that was investigated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive. In both the SPOTLIGHT and GLOW Phase 3 clinical trials, approximately 38 per cent of patients screened had tumours that were CLDN18.2 positive, defined as ≥75 per cent of tumour cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, assessed and confirmed using an in-vitro companion diagnostic test or medical device.1,2
As an investigational first-in-class monoclonal antibody (mAb), zolbetuximab targets and binds to CLDN18.2, a transmembrane protein expressed on cancer cells. In pre-clinical studies, zolbetuximab reduced the number of CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, leading to tumour growth inhibition.3
About VYLOY Support Program
Astellas is committed to supporting patients prescribed VYLOY through the VYLOY Support Program by offering coverage navigation, financial assistance, access to private infusion clinics, patient and caregiver education as well as specialty pharmacy dispensing. Patients should discuss if VYLOY is appropriate for them with their treating physician.
About Astellas Canada
Astellas Pharma Canada, Inc. is a Canadian affiliate of Tokyo-based Astellas Pharma Inc., a global life sciences company conducting business in more than 70 countries around the world. Astellas is committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at https://www.astellas.com
References
1 Shitara K, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023;401(10389):1655-1668.
2 Shah MA, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023;29(8):2133-2141.
3 Sahin U, et al. FAST: a randomised phase II study of zolbetuximab (IMAB362) plus EOX versus EOX alone for first-line treatment of advanced CLDN18.2-positive gastric and gastro-oesophageal adenocarcinoma. Ann Oncol. 2021;32(5):609-19.
SOURCE Astellas Pharma Canada, Inc.
