lazertinib
Drug Details
- Generic Name
- lazertinib
- Brand Names
- LAZCLUZE
- Application Number
- NDA219008
- Sponsor
- Janssen Biotech, Inc.
- NDC Codes
- 2
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- LAZERTINIB
Indications and Usage
1 INDICATIONS AND USAGE 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 )