The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 April 2025) approved trastuzumab deruxtecan (Enhertu) to treat people with solid tumours that have mutations in human epidermal growth factor 2 (known as HER2 positive cancers) that have spread to other parts of the body (metastatic disease) or cannot be removed by surgery (unresectable), and who have no alternative treatment options.  

This approval is an extension to the indication (use) of the medicine, which has previously been approved for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancers, who have received two or more prior anti-HER2-based regimens for non-small cell lung cancer with an activating HER2 mutation and HER2-postivie gastric cancer. 

Trastuzumab deruxtecan 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.    

As with any medicine, the MHRA will keep the safety and effectiveness of trastuzumab deruxtecan 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. 

Notes to editors  

1. The variation to the marketing authorisation was granted on 9 April 2025 to Daiichi Sankyo UK Ltd. 

2. 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

3. For more information about cancer, visit: https://www.nhs.uk/conditions/cancer/ 

4. 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.  

5. 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.  

6. The MHRA is an executive agency of the Department of Health and Social Care.  

7. For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.