Mississauga, ON, February 2, 2026 -- Bayer Inc. is pleased to announce that Health Canada has authorized HYRNUO™ (sevabertinib), oral tablets, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have HER2 (ERBB2) tyrosine kinase domain (TKD) mutations and who have received prior systemic therapy. Reviewed under Health Canada’s accelerated framework, including Project Orbis, HYRNUO™ has been granted a Notice of Compliance with conditions (NOC/c) pending the results of an additional trial to verify its clinical benefit. 1
HYRNUO™ is the first targeted therapy authorized in Canada for HER2-mutant NSCLC, addressing a significant unmet medical need for patients who previously had limited treatment options and a poor prognosis. HER2 mutations are a distinct subset of NSCLC, present in up to 4% of cases, and can be identified by molecular genetic testing of tumour samples (ex. Next-Generation Sequencing). 2,3,4
Authorization from Health Canada is based on results from the ongoing Phase I/II SOHO-01 trial (data cut: 14 October 2024), which demonstrated an objective response rate (ORR) of 65.8% (95% CI: 53.7%, 76.5%) and a median duration of response (DoR) of 6.8 months (95% CI: 5.2, Not Estimable). The observed disease control rate (DCR) was 82.2% (95% CI: 71.5%, 90.2%) and 27.1% of patients maintained a DoR of 6 or more months. The most common adverse reactions (>20%) in patients receiving HYRNUO™ were diarrhea (84.0%), rash (71.6%), and paronychia (30.9%). Serious adverse reactions reported in ≥2 patients included diarrhea (6.2%), nausea (2.5%), and hepatic function abnormal (2.5%). 1
"Sevabertinib is an exciting and important advance in treatment for Canadians with HER2-mutant non-small-cell lung cancer, offering hope to patients that previously had limited options.” said Dr. Natasha Leighl, Lung Site Lead, Division of Medical Oncology, Princess Margaret Cancer Centre. “This breakthrough treatment has major anticancer activity and helps us advance personalized treatment strategies in oncology."
Health Canada’s authorization follows the U.S. Food and Drug Administration approval on November 19, 2025, and highlights the drug’s potential to provide targeted treatment and improvement over existing therapies.
“This authorization underscores our commitment to address unmet medical needs through the advancement of innovative therapies,” said Shurjeel Choudhri, Senior Vice President, Medical and Scientific Affairs at Bayer Canada. “Sevabertinib has the potential to significantly improve outcomes for patients with HER2-mutant NSCLC, a population that has historically faced few effective treatment alternatives.”
About the SOHO-01 Trial
The SOHO-01 trial is an ongoing, open-label, multicenter Phase I/II study assessing the efficacy and safety of sevabertinib in patients with advanced HER2-mutant NSCLC in different cohorts of patients, including previously treated and naïve patients. 5
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. The Bayer brand stands for trust, reliability, and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.ca.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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References:
1. Bayer Inc. Hyrnuo™ (sevabertinb) Product Monograph, January 29,2026. Available at www.bayer.ca
2. Sharma R. Int J Clin Oncol. 2022; 27 (4):665-675.
3. Yu et al. Front Oncol 2022;12-860313.
4. Ren S et al. ESMO Open. 2022; 7(1): 100395
5. https://clinicaltrials.gov/study/NCT05099172