Lazcluze (lazertinib)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- lazertinib
- Company
- Janssen Cilag International NV
- Status
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 14 Nov 2024
- EU approval
- Mon 20 Jan 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006074
- ATC
- L01EB09
- Official record
- www.ema.europa.eu
Indication
Lazcluze in combination with amivantamab is indicated for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.