Posted by Michael Wonder on 03 Feb 2026
Health Canada grants authorization for Bayer’s Hyrnuo (sevabertinib) for previously treated patients with locally advanced or metastatic HER2-mutant non-small cell lung cancer
2 February 2026 - Bayer 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 whose tumours have HER2 (ERBB2) tyrosine kinase domain 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 pending the results of an additional trial to verify its clinical benefit.
