The Medicines and Healthcare products Regulatory Agency (MHRA) has approved sevabertinib (Hyrnuo) for the treatment of adults with advanced Non-Small Cell Lung Cancer (NSCLC) carrying HER2 mutations. The therapy is indicated for patients whose cancer has spread or cannot be surgically removed and has progressed following prior treatment.

The marketing authorisation was granted to Bayer PLC on April 1, 2026. Patients must undergo testing to confirm HER2 mutations before initiating treatment, ensuring appropriate use of the drug.

Sevabertinib is a protein kinase inhibitor designed to block the abnormal HER2 protein that drives cancer cell growth. By targeting this pathway, the drug can slow or halt tumour progression and, in some cases, shrink tumours. Clinical trial data showed positive responses in 71 percent of previously treated patients, with many responses lasting six months or longer.

Commenting on the approval, Julian Beach, interim Executive Director of healthcare quality and access at the MHRA, said the therapy provides a new treatment option for patients with HER2-positive lung cancer, particularly in advanced stages where alternatives are limited. He added that the regulator will continue to closely monitor the drug’s safety as its use expands.

Common side effects associated with sevabertinib include diarrhoea, skin reactions, inflammation of the mouth (stomatitis) and nail bed inflammation (paronychia). Patients are advised to consult healthcare professionals if they experience adverse effects and report them through the MHRA’s Yellow Card scheme.

The drug was approved under Project Orbis, an international collaboration involving regulatory agencies such as the US Food and Drug Administration, Health Canada and others. The initiative aims to accelerate access to promising cancer treatments by enabling simultaneous review across multiple countries.

The MHRA stated that it will cntinue to evaluate the safety and effectiveness of sevabertinib as part of its ongoing regulatory oversight.