By: IPP Bureau
Last updated : June 05, 2025 8:45 am
Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor
The Medicines and Healthcare products Regulatory Agency (MHRA) has 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.