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.
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.
Notes to editors
-
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.
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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.
