Prescription medicine
Lazertinib Brand names: Lazcluze
Lazertinib (Lazcluze) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the lazertinib FDA label on DailyMed (effective May 5, 2026, Janssen Biotech, Inc.); the NDA 219008 record on Drugs@FDA; every lazertinib label on DailyMed.
Highlights of the record
FDA label of May 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ].
Forms and strengths
- 80 mg
- 240 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 19, 2024 Lazcluze, Janssen Biotech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 1, 2041 Lazcluze tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 706 through July 30, 2026
What is lazertinib used for?
From the label: indications and usageLAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ]. LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
Conditions named in the indications of lazertinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (LAZCLUZE), Janssen Biotech, Inc., effective May 5, 2026 (SPL set c417f9ee-2027-4ed5-92ad-3c19266de16c), via openFDA; the full label on DailyMed
What does the patient leaflet for lazertinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking LAZCLUZE?LAZCLUZE can cause skin reactions. You should limit your time in the sun during and for 2 months after your treatment with LAZCLUZE. Wear protective clothing and use broad-spectrum UVA/UVB sunscreen during treatment with LAZCLUZE.
From the patient leaflet: How should I store LAZCLUZE?Store LAZCLUZE at room temperature between 68°F to 77°F (20°C to 25°C). Keep LAZCLUZE and all medicines out of the reach of children.
Source: FDA drug label (LAZCLUZE), Janssen Biotech, Inc., effective May 5, 2026 (SPL set c417f9ee-2027-4ed5-92ad-3c19266de16c), via openFDA; the full label on DailyMed
Is there a generic for lazertinib (Lazcluze)?
No generic lazertinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Lazcluze tablets: the compound patent runs to April 18, 2038, and the last listed entry to August 1, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the lazertinib label say about other medicines?
The lazertinib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 2 other medicines name lazertinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amivantamab | warnings and precautions | Monitor for signs and symptoms of VTE and treat as medically appropriate. Withhold LAZCLUZE and amivantamab based on severity. |
Source: FDA drug label (LAZCLUZE), Janssen Biotech, Inc., effective May 5, 2026 (SPL set c417f9ee-2027-4ed5-92ad-3c19266de16c), via openFDA; the full label on DailyMed
What do FAERS reports show for lazertinib?
The FDA Adverse Event Reporting System holds 706 reports that list lazertinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 32 are coded as a death and 175 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lazertinib?
26 other medicines are given the same way (oral) and in the same FDA class as lazertinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Lorlatinib | Lung cancer | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as lazertinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to lazertinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Lazertinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other