lazertinib

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lazertinib

CAS 1903008-80-9

 554.655, C30H34N8O3

2-PROPENAMIDE, N-(5-((4-(4-((DIMETHYLAMINO)METHYL)-3-PHENYL-1H-PYRAZOL-1-YL)-2-PYRIMIDINYL)AMINO)-4-METHOXY-2-(4-MORPHOLINYL)PHENYL)-

  • N-(5-((4-(4-((DIMETHYLAMINO)METHYL)-3-PHENYL-1H-PYRAZOL-1-YL)PYRIMIDIN-2-YL)AMINO)-4-METHOXY-2-MORPHOLINOPHENYL)ACRYLAMIDE
  • C-18112003-G
  • GNS 1480
  • GNS-1480
  • GNS1480
  • JNJ-73841937-AAA
  • YH 25448
  • YH-25448
  • YH25448

FDA APPROVED 

To treat non-small cell lung cancer, Lazcluze

Ingredient UNII CAS InChI Key
Lazertinib mesylate monohydrate WUT449BEG5 2411549-88-5 ZJPNGZUERUYZEG-UHFFFAOYSA-N

Lazertinib is an oral, third-generation, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).2,3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations.1 It was approved by the FDA on August 19, 2024.5 Lazertinib is used alone or in combination with other chemotherapeutic agents.4

Lazertinib, sold under the brand name Lazcluze and Leclaza, is an anti-cancer medication used for the treatment of non-small cell lung cancer.[1][2][3] 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.[2]

Lazertinib was approved for medical use in South Korea in January 2021,[4][5] and in the United States in August 2024.[2][6]

Medical uses

Lazertinib is indicated in combination with amivantamab for the first-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.[2

History

 

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.[2] 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.[2]

Society and culture

Lazertinib was approved for medical use in the United States in August 2024.[2]Names

Lazertinib is the international nonproprietary name.[7]
 
 
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References

  1. ^ Jump up to:a b c “Lazcluze- lazertinib tablet, film coated”. DailyMed. 20 August 2024. Retrieved 5 September 2024.
  2. ^ Jump up to:a b c d e f g “FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer”. U.S. Food and Drug Administration (FDA). 19 August 2024. Retrieved 21 August 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ Dhillon S (June 2021). “Lazertinib: First Approval”. Drugs. 81 (9): 1107–1113. doi:10.1007/s40265-021-01533-x. PMC 8217052. PMID 34028784.
  4. ^ “Yuhan wins approval as MFDS clear T790M EGFR TKI drug ‘Lazertinib'”. 바이오스펙테이터. Retrieved 23 August 2024.
  5. ^ Dhillon S (2021). “Lazertinib: First Approval”. Drugs. 81 (9): 1107–1113. doi:10.1007/s40265-021-01533-x. ISSN 0012-6667. PMC 8217052. PMID 34028784.
  6. ^ “Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer”. Johnson & Johnson (Press release). 20 August 2024. Retrieved 21 August 2024.
  7. ^ World Health Organization (2018). “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79”. WHO Drug Information. 32 (1). hdl:10665/330941.
  • Clinical trial number NCT04487080 for “A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA)” at ClinicalTrials.gov

 

 

Lazertinib
Clinical data
Trade names Lazcluze, Leclaza
License data
Routes of
administration		 By mouth
Drug class EGFR inhibitor
ATC code
Legal status
Legal status
Identifiers

CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
Chemical and physical data
Formula C30H34N8O3
Molar mass 554.655 g·mol−1
3D model (JSmol)

/////////lazertinib, C-18112003-G, GNS 1480, GNS-1480, GNS1480, JNJ-73841937-AAA, YH 25448, YH-25448, YH25448, Lazcluze, FDA 2024, APPROVALS 2024

COC1=C(NC2=NC=CC(=N2)N2C=C(CN(C)C)C(=N2)C2=CC=CC=C2)C=C(NC(=O)C=C)C(=C1)N1CCOCC1

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