{"id":24324,"date":"2026-05-28T10:07:23","date_gmt":"2026-05-28T10:07:23","guid":{"rendered":"https:\/\/beonemedicines.ca\/en\/?post_type=pressreleases&p=24324"},"modified":"2026-05-28T10:07:24","modified_gmt":"2026-05-28T10:07:24","slug":"beone-medicines-receives-positive-reimbursement-recommendations-from-cda-amc-and-inesss-for-tevimbra-in-first-line-nasopharyngeal-carcinoma","status":"publish","type":"pressreleases","link":"https:\/\/beonemedicines.ca\/en\/pressreleases\/beone-medicines-receives-positive-reimbursement-recommendations-from-cda-amc-and-inesss-for-tevimbra-in-first-line-nasopharyngeal-carcinoma\/","title":{"rendered":"BeOne Medicines Receives Positive Reimbursement Recommendations from CDA-AMC and INESSS for TEVIMBRA in First-Line Nasopharyngeal Carcinoma"},"content":{"rendered":"\r\n
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Canada\u2019s Health Technology Assessment (HTA) agencies affirm the clinical value of TEVIMBRA in first-line recurrent or metastatic nasopharyngeal carcinoma (NPC), a rare form of head and neck cancer<\/em>
\n <\/p>\n

Positive reimbursement recommendations mark an important step toward securing public funding for eligible patients who currently lack a first-line NPC chemotherapy-immunotherapy treatment option in Canada<\/em><\/center><\/p>\n

TORONTO, Ontario<\/strong> \u2013 May 28, 2026 \u2013 BeOne Medicines<\/a>, a global oncology company, today announced that Canada\u2019s Drug Agency (CDA-AMC) and the Institut national d\u2019excellence en sant\u00e9 et en services sociaux (INESSS), issued positive reimbursement recommendations for TEVIMBRA\u00ae (tislelizumab for injection) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). These recommendations follow Health Canada\u2019s approval of TEVIMBRA in December 2025 for this indication and represent an important step toward access for patients, as there is currently no publicly funded first-line immunotherapy option for recurrent or metastatic NPC in Canada.<\/p>\n

Nasopharyngeal carcinoma is a rare form of head and neck cancer that arises in the upper part of the throat behind the nose.1<\/sup> NPC affects a small but significant number of Canadians each year and there are considerable disparities in accessing immunotherapy as part of first-line treatment for recurrent or metastatic NPC.2<\/sup><\/p>\n

The recommendations are based on assessments by CDA-AMC and INESSS of clinical and economic evidence, as well as input from physicians, patient groups, and public drug programs. The clinical evidence is based on results from the RATIONALE-309 trial (NCT03924986<\/a>), a multicenter, Phase 3 study of TEVIMBRA in combination with chemotherapy (gemcitabine and cisplatin) versus placebo combined with gemcitabine and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer. The primary endpoint was met at the first prespecified interim analysis in which TEVIMBRA significantly prolonged progression free survival (PFS) in the intention-to-treat (ITT) population. TEVIMBRA plus chemotherapy was generally well tolerated. The most common Grade 3 or higher treatment-emergent adverse events (\u2265 20%) associated with TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, and leukopenia.3<\/sup> Recently published three-year follow-up data show that TEVIMBRA plus chemotherapy demonstrates a sustained and clinically meaningful PFS improvement, reinforcing the long-term efficacy and safety profile of the treatment regimen.4<\/sup><\/p>\n

\u201cThese positive recommendations from CDA-AMC and INESSS represent an important milestone in the Canadian reimbursement pathway,\u201d said Kristian Stubbs, General Manager, Canada, BeOne Medicines. \u201cWe will continue to work collaboratively with provincial governments and other stakeholders to help bring this important treatment option to eligible patients across Canada.\u201d<\/p>\n

Additional information regarding the reimbursement recommendations, including clinical criteria and associated conditions, is available on the CDA-AMC<\/a> and INESSS<\/a> websites.<\/p>\n

Healthcare providers and patients may learn more about accessing TEVIMBRA through myBeOneSupport, available at 1-833-234-4366.<\/p>\n

About Nasopharyngeal Cancer (NPC) in Canada:<\/strong>
\nNasopharyngeal cancer (NPC) is a type of head and neck cancer that starts in the nasopharynx, the upper throat passage behind the nose.1<\/sup> NPC is often diagnosed at advanced stages due to its deep anatomical location and mild early symptoms, making early detection challenging.5<\/sup> In Canada, NPC is considered rare and occurs at rates generally below 1 per 100,000 in non-endemic regions; however, higher incidence has been reported in certain populations, including Inuit communities in Nunavut and the Northwest Territories (~10 per 100,000).2<\/sup> Because NPC statistics are not reported separately in Canada, it is captured within the broader head and neck cancer category; in 2025, an estimated 8,100 Canadians were expected to be diagnosed and approximately 2,200 to die from the disease.6<\/sup><\/p>\n

About TEVIMBRA (tislelizumab)<\/strong>
\nTislelizumab is a humanized immunoglobulin G4 (IgG4) variant monoclonal antibody against PD-1. Binding to the extracellular domain of PD-1 receptor blocks the interaction with both PD-L1 and PD\u2011L2 ligands, inhibiting T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumours and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumours.3<\/sup><\/p>\n

TEVIMBRA is the foundational asset of BeOne\u2019s solid tumour portfolio. The global TEVIMBRA clinical development program includes more than 15,000 patients enrolled to date in 30+ countries and regions across 72 trials, including 22 registration-enabling studies.<\/p>\n

For more information, please consult the TEVIMBRA Product Monograph located here<\/a>.<\/p>\n

IMPORTANT SAFETY INFORMATION<\/strong><\/p>\n

Indications & Clinical Use:<\/strong><\/p>\n

TEVIMBRA (tislelizumab for injection) in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).<\/p>\n

TEVIMBRA (tislelizumab for injection) as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after one prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.<\/p>\n

Pediatrics (<18 years of age):<\/strong><\/p>\n

No data are available; therefore, Health Canada has not authorized an indication for pediatric use.<\/p>\n

Geriatrics (\u226565 years of age):<\/strong><\/p>\n

Based on population pharmacokinetic (PK) analysis, no clinically relevant differences in the PK of TEVIMBRA were observed between patients aged <65 years, patients aged between 65 and 75 years, and patients aged >75 years. Limited safety and efficacy information is available for TEVIMBRA in NPC patients \u2265 65 years.<\/p>\n

Contraindications:<\/strong><\/p>\n

TEVIMBRA is contraindicated in patients who are hypersensitive to this drug (tislelizumab) or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.<\/p>\n

Serious Warnings and Precautions:<\/strong><\/p>\n

Immune-mediated adverse reactions:<\/strong> TEVIMBRA may cause severe and fatal immune-mediated adverse reactions, in any organ system or tissue, including: colitis, endocrinopathies, hepatitis, myocarditis, myositis, nephritis with renal dysfunction, organ transplant rejection, pancreatitis, pneumonitis, and severe cutaneous adverse reactions (SCARS e.g., Steven\u2019s Johnson Syndrome and Toxic Epidermal Necrolysis).<\/p>\n

Infusion-related reactions:<\/strong> TEVIMBRA can cause severe or life-threatening infusion-related reactions including hypersensitivity and anaphylaxis.<\/p>\n

Patients receiving allogenic hematopoietic stem cell transplantation (HSCT):<\/strong> Fatal and other serious complications can occur in patients receiving HSCT before or after being treated with a PD-1\/PD-L1 blocking antibody.<\/p>\n

Other Relevant Warnings and Precautions:<\/strong><\/p>\n