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| Clinical data | |
|---|---|
| Trade names | Lazcluze, others |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624058 |
| License data | |
| Routes of administration | By mouth |
| Drug class | EGFR inhibitor |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
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| CAS Number | |
| PubChemCID | |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider | |
| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C30H34N8O3 |
| Molar mass | 554.655 g·mol−1 |
| 3D model (JSmol) | |
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Lazertinib, sold under the brand nameLazcluze among others, is ananti-cancer medication used for the treatment ofnon-small cell lung cancer.[1][4][5] It is a kinase inhibitor of epidermal growth factor receptor.[1]
The most common adverse reactions include rash, nail toxicity, infusion-related reactions (amivantamab), musculoskeletal pain, edema, stomatitis, venous thromboembolism, paresthesia, fatigue, diarrhea, constipation, COVID-19 infection, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity.[4]
Lazertinib was approved for medical use in South Korea in January 2021,[6][7] in the United States in August 2024,[4][8][9][10] and in the European Union in January 2025.[2][3]
Lazertinib isindicated in combination withamivantamab for thefirst-line treatment of adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations.[1][4][2][3]
Efficacy was evaluated in MARIPOSA (NCT04487080), a randomized, active-controlled, multicenter trial of 1074 participants with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic non-small cell lung cancer and no prior systemic therapy for advanced disease.[4] Participants were randomized (2:2:1) to receive lazertinib in combination with amivantamab, osimertinib monotherapy, or lazertinib monotherapy (an unapproved regimen for non-small cell lung cancer) until disease progression or unacceptable toxicity.[4]
Lazertinib was approved for medical use in the United States in August 2024.[4]
In November 2024, theCommittee for Medicinal Products for Human Use of theEuropean Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Lazcluze, intended in combination with amivantamab, for the treatment of non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.[2] The applicant for this medicinal product is Janssen-Cilag International NV.[2][11] Lazertinib was authorized for medical use in the European Union in January 2025.[2][3]
Lazertinib is theinternational nonproprietary name.[12]
Lazertinib is sold under the brand name Lazcluze.[1][2]
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