The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 6 March 2025, approved lazertinib (brand name
Lazcluze) for adults with non-small cell lung cancer that has
spread to other parts of the body and has undergone specific
changes in a gene called epidermal growth factor receptor (EGFR).
It is to be used in combination with an approved cancer medicine
called amivantamab.
Lazertinib works by blocking EGFR and may help to slow or stop
the lung cancer from growing. It may also help to reduce the size
of the tumour. It is taken daily in tablet form.
Beach, MHRA Interim Executive
Director of Healthcare Quality and Access, said:
Patient safety is our top priority, which is why I am pleased to
confirm approval of Lazertinib for the treatment of adults with
non-small cell lung cancer.
We're confident that the appropriate regulatory standards of
safety, quality and effectiveness for the approval of this new
formulation have been met.
As with all products, we will keep its safety under close review.
Lazertinib has been evaluated in a clinical trial, in which a
total of 1074 participants were randomised to receive one of
three treatments. The lazertinib and amivantamab combination
treatment was compared against treatment with lazertinib alone,
and against treatment with another cancer medicine osimertinib.
Participants who received the combination treatment had a longer
period without progression of their disease, as compared to
patients who received the other two treatments.
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Some of the most common side
effects are skin problems (such as rash, itching and dry skin),
decreased appetite, nausea, muscle spasms, vomiting and
fever.
For the full list of all side effects reported with this
medicine, see Section 4 of the Patient Information Leaflet (PIL)
or the SmPC available on the MHRA website.
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 MHRA 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.
ENDS
Notes to editors
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The new marketing authorisation was granted on 6 March 2025
to Janssen-Cilag Ltd
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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.
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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.
