BeOne Medicines

⚕️💊Health Canada Approves TEVIMBRA® (tislelizumab for injection) in Combination with Gemcitabine and Cisplatin for the First-Line Treatment of Adult Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma

Saturday, 03 January 2026 12:00.PM

- Nasopharyngeal Carcinoma is a rare and debilitating disease with limited effective treatment options currently available to Canadian patients.
- Approval supported by results of the RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival. -

BeOne Medicines, a global oncology company, today announced that Health Canada has granted a Notice of Compliance (NOC), approving TEVIMBRA® (tislelizumab for injection) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). This is the first approved indication for TEVIMBRA in Canada.

Nasopharyngeal carcinoma is a rare form of head and neck cancer that arises in the upper part of the throat behind the nose.1 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

"This approval represents an important milestone and treatment advancement for Canadians diagnosed with nasopharyngeal carcinoma," said Dr. Desiree Hao, Head and Neck Medical Oncologist at Arthur J.E. Child Comprehensive Cancer Centre and Professor of Medicine, University of Calgary. "Adult patients with recurrent or metastatic NPC have long faced limited therapeutic choices. The arrival of TEVIMBRA for Canadian NPC patients is a welcomed treatment option to help address this critical unmet need."

The Health Canada approval of TEVIMBRA was based upon the results from RATIONALE-309 (NCT03924986), a multicentre, Phase 3 randomized, double-blind trial, in which patients received either TEVIMBRA in combination with gemcitabine plus cisplatin, or placebo in combination with gemcitabine plus cisplatin. The primary endpoint was met at the first prespecified interim analysis demonstrating that TEVIMBRA significantly prolonged progression free survival (PFS) in the intent-to-treat (ITT) population (HR 0.52 [95% CI:0.38, 0.73] p<0.0001), showing a 48% reduction in the risk of disease progression or death. The median PFS in the TEVIMBRA plus chemotherapy arm was 9.2 months compared to 7.4 months in the placebo plus chemotherapy arm.3

TEVIMBRA plus chemotherapy was generally well tolerated. The most common ≥Grade 3 treatment-emergent adverse events (≥ 20%) associated with TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, and leukopenia.3

"This Health Canada approval is an important step in making a new treatment option available to Canadian patients living with NPC," said Kristian Stubbs, General Manager, Canada, BeOne Medicines. "We believe that no one should face this devastating disease alone and we are committed to making TEVIMBRA broadly accessible to Canadian NPC patients. We look forward to partnering with stakeholders who share a sense of urgency to improve the standard of care for NPC patients in Canada."

TEVIMBRA is anticipated to be commercially available in the first half 2026.

SOURCE: BeOne Medicines

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