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FDA Medication Tracker

← All approvals · Cancer · 2024

Lazcluze (lazertinib)

The FDA approved Lazcluze (lazertinib) on August 19, 2024 to treat non-small cell lung cancer.
Brand name
Lazcluze
Generic name
lazertinib
FDA approval date
August 19, 2024
Approved use (FDA wording)
To treat non-small cell lung cancer
Company
Janssen Biotech
Application
NDA219008
Dosage form / route
TABLET · ORAL
Drug class (EPC)
Kinase Inhibitor [EPC]
Boxed warning on label
Not listed
Category on this site
Cancer

Indications and usage, from the FDA label

LAZCLUZE, 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. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.