Lazertinib, sold under the brand name Lazcluze among others, is an

anti-cancer medication Chemotherapy (often abbreviated chemo, sometimes CTX and CTx) is the type of cancer treatment that uses one or more anti-cancer drugs ( chemotherapeutic agents or alkylating agents) in a standard regimen. Chemotherapy may be given with a cu ...

used for the treatment of

non-small cell lung cancer Non-small-cell lung cancer (NSCLC), or non-small-cell lung carcinoma, is any type of epithelial lung cancer other than small-cell lung cancer (SCLC). NSCLC accounts for about 85% of all lung cancers. As a class, NSCLCs are relatively insensitiv ...

. It is a kinase inhibitor of epidermal growth factor receptor. 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. Lazertinib was approved for medical use in South Korea in January 2021, in the United States in August 2024, and in the European Union in January 2025.

Medical uses

Lazertinib is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

, in combination with amivantamab, for the

first-line treatment A therapy or medical treatment is the attempted remediation of a health problem, usually following a medical diagnosis. Both words, ''treatment'' and ''therapy'', are often abbreviated tx, Tx, or Tx. As a rule, each therapy has indications an ...

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.

History

Efficacy was evaluated in MARIPOSA (NCT04487080), a randomized, active-controlled, multi-center 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. Participants were randomized (2:2:1) to receive lazertinib in combination with amivantamab,

osimertinib Osimertinib, sold under the brand name Tagrisso, is a medication used to treat non-small-cell lung carcinomas with specific mutations. It is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor. The most common side e ...

monotherapy, or lazertinib monotherapy (an unapproved regimen for non-small cell lung cancer) until disease progression or unacceptable toxicity. The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) approved lazertinib in combination with amivantamab based on evidence from one clinical trial (MARIPOSA, NCT04487080) using data from 858 adult participants with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R substitution mutations. The trial was conducted at 204 sites in 26 countries including China, South Korea, Brazil, Japan, Malaysia, Spain, Taiwan, Russian Federation, Turkey, Thailand, Mexico, France, Italy, Ukraine, Argentina, Poland, the United States, India, Australia, Portugal, Israel, the United Kingdom, Germany, Belgium, Hungary, and Netherlands. Of the 858 participants, 12 were enrolled at sites in the United States. Among the 858 participants, all were evaluated for efficacy and 849 were evaluated for safety.

Society and culture

Legal status

Lazertinib was approved for medical use in the United States in August 2024. In November 2024, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

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. The applicant for this medicinal product is Janssen-Cilag International NV. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Lazertinib was authorized for medical use in the European Union in January 2025.

Names

Lazertinib is the international nonproprietary name. Lazertinib is sold under the brand name Lazcluze and in South Korea as Leclaza.

References

External links

* {{Authority control Tyrosine kinase inhibitors 4-Morpholinyl compounds Pyrimidines Methoxy compounds Anilides Guanidines Pyrazoles Dimethylamino compounds