NDAORALTABLETPriority Review
Approved
Aug 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
17
Data completeness
6/8 — Strong
Priority Review
LAZCLUZE (lazertinib) by Johnson & Johnson is kinase inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2024.
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LAZCLUZE (lazertinib) is an oral small-molecule kinase inhibitor approved by the FDA on August 19, 2024. It is indicated for kinase-driven malignancies and works by inhibiting aberrant kinase signaling in cancer cells. The drug represents Johnson & Johnson's entry into the competitive kinase inhibitor space.
Growth14.9 years to LOE
Early-stage growth product with J&J backing offers expansion opportunities; Medical Affairs team building phase underway.
Mechanism of Action
Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (17)
A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC
Started Jul 2026
68 enrolled
Carcinoma, Non-Small-Cell Lung
A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Started Dec 2024
480 enrolled
Carcinoma, Non-Small-Cell Lung
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
Started Feb 2024
305 enrolled
Carcinoma, Non-Small-Cell Lung
A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants
Started May 2023
72 enrolled
Healthy
Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth Factor Receptor Mutations
Started May 2023
54 enrolled
Metastatic Non-small Cell Lung Cancers
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.