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Another NameLuciLazer、Leclaza
IndicationsIt is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion
Reg No.03 L 1326/25
Inspection NO.535-25
Lazertinib from Lucius Pharmaceuticals is a highly effective and well-tolerated oral kinase inhibitor. The combination therapy has demonstrated significant survival benefits in clinical studies, providing patients with a more valuable treatment option.
The following is a summary of key information about lazertinib.
The main active ingredient is lazertinib mesylate monohydrate.
It is indicated for adult patients with advanced non-small cell lung cancer (NSCLC) whose EGFR mutations have been confirmed by an FDA-approved test.
The recommended dose is 240 mg orally once daily, which can be taken with or without food, and must be used in combination with amivantamab.
Patients of childbearing potential must use effective contraceptive measures.
Use during lactation is not recommended.
No dosage adjustment is required for elderly patients or those with mild to moderate hepatic or renal impairment.
There is currently no specific antidote for overdose. Symptomatic and supportive treatment should be administered in case of drug overdose.
Store at room temperature between 20°C and 25°C; short-term storage within the range of 15°C to 30°C is permitted.
Lazertinib reaches peak plasma concentration 2–4 hours after oral administration, has a half-life of approximately 3.7 days, and is mainly excreted via feces.
FDA，2024.08
