MHRA approves aumolertinib to treat non-small cell lung cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 3 June 2025, approved aumolertinib (Aumseqa) for adult patients with non-small cell lung cancer (NSCLC).

Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor (EGFR) and who have not yet received treatment for their cancer which has spread to other parts of the body (metastatic cancer). In certain circumstances it can be used even if the metastatic cancer has been treated before.

This medicine is administered in tablet form, to be taken orally.

Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said: 

“Patient safety is our top priority, and I’m pleased to confirm that aumolertinib has met the MHRA’s standards for safety, quality and effectiveness.

 “This approval offers a new treatment option for patients with advanced non-small cell lung cancer who have tested positive for EGFR mutations – a group for whom targeted therapies can be particularly important.

 “As with all products, we will keep aumolertinib’s safety under close review.”

Aumolertinib works by blocking EGFR and may help to slow or stop the lung cancer from growing. It may also help reduce the size tumour.

In a Phase 3 clinical trial, aumolertinib was found to reduce the risk of disease progression or death by 54% in patients with advanced or metastatic NSCLC who had specific EGFR mutations, when compared to an already-approved cancer treatment called gefitinib.

Like all medicines, this medicine can cause side effects in some people. A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), available on the MHRA website within 7 days of approval.  

Anyone who suspects they are having a side effect from this medicine should talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Cardv scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.    

• The new marketing authorisation was granted on 3 June 2025 to SFL Pharmaceuticals Deutschland GmbH.
• This product was submitted and approved via a national procedure.  
• 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 judgements to ensure that the benefits justify any risks.  
• The MHRA is an executive agency of the Department of Health and Social Care.  

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Aaron Kearney

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