Posted by Michael Wonder on 03 Apr 2026
Sevabertinib approved to treat adults with HER2 positive lung cancer that has spread or cannot be removed by surgery
2 April 2026 - The MHRA has approved sevabertinib (Hyrnuo) to treat adults with advanced non-small cell lung cancer with HER2 mutations, that has spread to other parts of the body or cannot be removed by surgery.
The marketing authorisation was granted to Bayer on 1 April 2026.
Sevabertinib has been approved through Project Orbis, a global partnership between the MHRA, the Therapeutics Goods Administration (Australia(, Health Canada, the Health Sciences Authority (Singapore), Swissmedic, Agência Nacional de Vigilância Sanitária in Brazil and the Ministry of Health (Israel), coordinated by the FDA.
