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lazertinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tyrosine kinase inhibitors | 5832 | 1903008-80-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Lazertinib is a kinase inhibitor of epidermal growth factor receptor (EGFR) that inhibits EGFR exon 19 deletions and exon 21 L858R substitution mutations at lower concentrations than wild-type EGFR. In human NSCLC cells and mouse xenograft models of EGFR exon 19 deletions or EGFR L858R substitution mutations, lazertinib demonstrated anti-tumor activity. Treatment with lazertinib in combination with amivantamab increased in vivo anti-tumor activity compared to either agent alone in a mouse xenograft model of human NSCLC with an EGFR L858R mutation.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 19, 2024 | FDA | : Janssen Biotech, Inc | |
| Jan. 20, 2025 | EMA | Janssen Cilag International NV |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Paronychia | 75.22 | 44.13 | 14 | 264 | 7992 | 90620177 |
| Neuropathy peripheral | 46.83 | 44.13 | 17 | 261 | 136953 | 90491216 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Paronychia | 83.07 | 49.00 | 17 | 464 | 11064 | 110577754 |
| Neuropathy peripheral | 70.21 | 49.00 | 27 | 454 | 179250 | 110409568 |
| Infusion related reaction | 65.37 | 49.00 | 32 | 449 | 381130 | 110207688 |
| Dermatitis acneiform | 52.78 | 49.00 | 12 | 469 | 12683 | 110576135 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01EB09 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors |
| MeSH PA | D000092004 | Tyrosine Kinase Inhibitors |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D047428 | Protein Kinase Inhibitors |
| FDA MoA | N0000175082 | Kinase Inhibitors |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000182141 | Cytochrome P450 3A4 Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Related Drugs by ATC class:
L01EB Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors 8 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Non-small cell lung cancer | indication | 254637007 | DOID:3908 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 80MG BASE | LAZCLUZE | JANSSEN BIOTECH | N219008 | Aug. 19, 2024 | RX | TABLET | ORAL | 9593098 | Oct. 13, 2035 | FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB |
| EQ 80MG BASE | LAZCLUZE | JANSSEN BIOTECH | N219008 | Aug. 19, 2024 | RX | TABLET | ORAL | 11981659 | April 18, 2038 | FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB |
| EQ 80MG BASE | LAZCLUZE | JANSSEN BIOTECH | N219008 | Aug. 19, 2024 | RX | TABLET | ORAL | 12599606 | May 14, 2040 | FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, BY ADMINISTRATION OF EQ 80 MG BASE LAZERTINIB IN COMBINATION WITH AMIVANTAMAB |
| EQ 80MG BASE | LAZCLUZE | JANSSEN BIOTECH | N219008 | Aug. 19, 2024 | RX | TABLET | ORAL | 11879013 | May 21, 2040 | FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB |
| EQ 80MG BASE | LAZCLUZE | JANSSEN BIOTECH | N219008 | Aug. 19, 2024 | RX | TABLET | ORAL | 11850248 | Aug. 1, 2041 | FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 80MG BASE | LAZCLUZE | JANSSEN BIOTECH | N219008 | Aug. 19, 2024 | RX | TABLET | ORAL | Aug. 19, 2029 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Epidermal growth factor receptor | Kinase | INHIBITOR | IC50 | 7.53 | DRUG LABEL | DRUG LABEL | |||
| Receptor tyrosine-protein kinase erbB-2 | Kinase | Ki | 6.36 | CHEMBL | |||||
| Tyrosine-protein kinase SYK | Kinase | INHIBITOR | IC50 | 6.70 | IUPHAR | ||||
| Tyrosine-protein kinase SYK | Kinase | INHIBITOR | IC50 | 6.70 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| CHEMBL4558324 | ChEMBL_ID |
| C000707992 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB16216 | DRUGBANK_ID |
| 4043347 | VANDF |
| C4724849 | UMLSCUI |
| CHEBI:757712 | CHEBI |
| CHEMBL6068478 | ChEMBL_ID |
| 10587 | INN_ID |
| 121269225 | PUBCHEM_CID |
| 388578 | MMSL |
| 43083 | MMSL |
| d10215 | MMSL |
| 10136 | IUPHAR_LIGAND_ID |
| 4A2Y23XK11 | UNII |
| 2691150 | RXNORM |
| 1373927003 | SNOMEDCT_US |
| 933451401000036107 | SNOMEDCT_US |
| D11980 | KEGG_DRUG |
| 019839 | NDDF |
| 019840 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| LAZCLUZE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-080 | TABLET, FILM COATED | 80 mg | ORAL | NDA | 32 sections |
| LAZCLUZE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-080 | TABLET, FILM COATED | 80 mg | ORAL | NDA | 32 sections |
| LAZCLUZE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-240 | TABLET, FILM COATED | 240 mg | ORAL | NDA | 32 sections |
| LAZCLUZE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-240 | TABLET, FILM COATED | 240 mg | ORAL | NDA | 32 sections |