Astellas Pharma Canada has announced Health Canada’s approval of Vyloy (zolbetuximab for injection) in combination with chemotherapy to treat adult patients with advanced gastric cancer.
Vyloy is approved as first-line treatment for locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
It is to be used with fluoropyrimidine- and platinum-based chemotherapy for patients with CLDN 18.2 positive tumours as determined by a validated test.
In addition, Canada’s Drug Agency (CDA-AMC) recently issued a draft recommendation supporting the conditional reimbursement of Vyloy.
Health Canada’s decision closely follows China’s National Medical Products Administration (NMPA) approval for the same indication.
The US Food and Drug Administration (FDA) granted approval for the drug in October 2024. This followed similar decisions by the European Commission in September 2024, the UK Medicines and Healthcare Products Regulatory Agency in August 2024, and Japan’s Ministry of Health, Labour and Welfare in March 2024.
Furthermore, Astellas Pharma is awaiting additional regulatory reviews for zolbetuximab in other regions worldwide.
Astellas Pharma Canada oncology business unit head Graham Watson said: “The approval of Vyloy in Canada as the first and only targeted therapy to treat CLDN18.2 positive gastric or GEJ cancer patients marks a significant milestone in our unwavering commitment to advancing scientific progress for challenging diseases.
“We’re also pleased that CDA-AMC provided a positive draft recommendation, which is another key milestone towards making Vyloy available for Canadian patients.
“Across Astellas, we are proud of our shared vision for precision medicines and the ways they can help transform the management of advanced cancers.
“With this approval, our local team is ready to support Canadian health care professionals and the gastric and GEJ cancer patients they treat.”
Data from the Phase 3 SPOTLIGHT and GLOW trials support Health Canada’s approval of zolbetuximab.
Treatment with zolbetuximab showed significant improvements in progression-free survival (PFS) and overall survival (OS) in patients with gastric or GEJ cancers.
Serious treatment emergent adverse events (TEAEs) were similar between zolbetuximab and control groups.
An expanded Phase 2 trial of zolbetuximab is evaluating its safety and efficacy with gemcitabine and nab-paclitaxel in metastatic pancreatic adenocarcinoma patients with CLDN18.2-positive tumours.
Additionally, ASP2138, a bispecific monoclonal antibody, is being studied in a Phase 1/1b trial.
