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lazertinib

Lazcluze · ATC code L01EB09

Key facts
Active substance
lazertinib
ATC code
L01EB09
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Lazcluze 80 mg film-coated tablets / Lazcluze 240 mg film-coated tablets
Marketing authorisation holder
Janssen Cilag International NV
Information as of
2026-10-29

Key facts

Lazertinib (Lazcluze) is an oral EGFR tyrosine kinase inhibitor used with amivantamab for first-line treatment of advanced EGFR-mutated non-small cell lung cancer.

What it is used for

  • In combination with amivantamab for first-line treatment of adults with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
  • EGFR mutation status must first be established with a validated test (tumour tissue or plasma).

Dosing

  • 240 mg once daily in combination with amivantamab; take before amivantamab on the same day. For amivantamab dosing see its SmPC.
  • Dose reductions for adverse reactions: 160 mg once daily, then 80 mg once daily, then discontinue.
  • Prophylactic anticoagulation with a DOAC or low molecular weight heparin at initiation; vitamin K antagonists are not recommended.
  • Prophylaxis of skin and nail reactions with oral and topical antibiotics, moisturiser and sun protection.
  • A missed dose can be taken within 12 hours; continue until progression or unacceptable toxicity.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Interstitial lung disease/pneumonitis, including fatal events; interrupt for symptoms and permanently discontinue if confirmed.
  • Venous thromboembolic events (DVT, PE), including fatal events; prophylactic anticoagulation.
  • Skin and nail reactions; limit sun exposure during and for 2 months after therapy.
  • Hepatotoxicity and eye disorders – see the full text.

Side effects

  • Most frequent (with amivantamab): rash (89%), nail toxicity (71%), infusion-related reaction (63%), hypoalbuminaemia (48%), hepatotoxicity (47%), oedema (47%), stomatitis (43%), venous thromboembolism (37%), paraesthesia (34%), fatigue (32%).
  • Most frequent serious reactions: venous thromboembolism (11%), pneumonia (4.0%), rash (3.1%), ILD/pneumonitis (2.9%).

Interactions

  • Avoid strong CYP3A4 inducers (e.g. carbamazepine, phenytoin, rifampicin, St John's wort); use moderate inducers with caution.
  • Lazertinib may increase plasma concentrations of CYP3A4 and BCRP substrates.

Pregnancy and breastfeeding

  • Women: effective contraception during and up to 3 weeks after treatment.
  • Men: use a condom and do not donate or store semen during treatment and for 3 weeks after the last dose.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • LazcluzeJanssen Cilag International NV · EMEA/H/C/006074

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Lazcluze
Liechtenstein
Lazcluze
Norway
Lazcluze

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Lazcluze – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/lazcluze-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.