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.
Julian 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.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
