Treats locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal…. Sold as Lazcluze. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Lazertinib Mesylate (sold as Lazcluze), first approved Aug 19, 2024, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Lazcluze | Part D | $58.4M | +719% | 813 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 19, 2024 | LazcluzeNDA 219008 · New molecular entity | Janssen Biotech | 3 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
