Sevabertinib (Hyrnuo) Approved for Advanced HER2-Positive Lung Cancer
Summary
The MHRA has granted marketing authorisation to Bayer PLC on 1 April 2026 for sevabertinib (Hyrnuo), a protein kinase inhibitor indicated for adults with advanced non-small cell lung cancer (NSCLC) harbouring HER2 mutations that has spread or is unresectable. The approval, coordinated under Project Orbis alongside FDA, TGA, Health Canada, HSA Singapore, Swissmedic, ANVISA Brazil, and Israel's Ministry of Health, was based on clinical trial evidence showing positive responses in 71% of previously treated patients, with many responses lasting six months or longer.
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
The MHRA has approved sevabertinib (Hyrnuo) as a new treatment for adults with advanced HER2-positive non-small cell lung cancer that has spread or cannot be removed by surgery. The medicine is a protein kinase inhibitor targeting the HER2 protein and is indicated for patients whose cancer has progressed following prior treatment and whose tumours carry specific HER2 gene mutations. Patients must be tested for these mutations before starting treatment. Marketing authorisation was granted to Bayer PLC on 1 April 2026.
Healthcare providers and pharmaceutical companies should note that this approval was coordinated through Project Orbis, an international partnership designed to expedite patient access to promising cancer treatments. Bayer PLC as the marketing authorisation holder will be subject to ongoing safety monitoring by the MHRA. Common side effects include diarrhoea, skin reactions, stomatitis, and paronychia.
Archived snapshot
Apr 2, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Press release
Sevabertinib approved to treat adults with HER2-positive lung cancer that has spread or cannot be removed by surgery
As with any medicine, the MHRA will keep the safety and effectiveness of sevabertinib under close review.
From: Medicines and Healthcare products Regulatory Agency Published 2 April 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved sevabertinib (Hyrnuo) to treat adults with advanced non-small cell lung cancer (NSCLC) with HER2 mutations, that has spread to other parts of the body or cannot be removed by surgery.
Sevabertinib is indicated for patients whose cancer has progressed following prior treatment and whose tumours have specific changes in the HER2 gene. Patients should be tested for these mutations before starting treatment to ensure the medicine is suitable for them.
Sevabertinib is a protein kinase inhibitor that works by blocking abnormal HER2 protein which drives the growth of cancer cells. By targeting this protein, the medicine can help to slow or stop the cancer from growing and, in some cases, shrink the tumour. Clinical trial evidence shows sevabertinib produced positive responses in 71% of previously treated patients with advanced HER2 mutations, with many positive responses lasting six months or longer.
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said:
The approval of sevabertinib (Hyrnuo) provides a new treatment for adults with HER2-positive lung cancer that has spread or cannot be removed by surgery.
As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.
The most common side effects of sevabertinib include diarrhoea, skin reactions, stomatitis (inflammation of the mouth) and paronychia (inflammation of skin surrounding toenails). Patients should speak to their healthcare professional if they experience any side effects.
As with any medicine, the MHRA will keep the safety and effectiveness of sevabertinib under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Sevabertinib has been approved through Project Orbis, a global partnership between the MHRA, the Therapeutics Goods Administration in Australia, Health Canada, the Health Sciences Authority in Singapore, Swissmedic, Agência Nacional de Vigilância Sanitária in Brazil and Israel’s Ministry of Health, coordinated by the US Food and Drug Administration. This programme reviews and approves promising cancer drugs, helping patients to access treatments more quickly.
Notes to editors
- The marketing authorisation was granted to Bayer PLC on 1 April 2026.
- The aim of Project Orbis is to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies. For more information, see: Project Orbis
- For more information about lung cancer, visit: https://www.nhs.uk/conditions/lung-cancer
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
Share this page
The following links open in a new tab
Updates to this page
Published 2 April 2026
Mentioned entities
Parties
Related changes
Get daily alerts for MHRA Guidance & Safety
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from MHRA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when MHRA Guidance & Safety publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.