Lazertinib(Leclaza)

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.

Active Ingredient

The main active ingredient is lazertinib mesylate monohydrate.

Indicated Population

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.

Dosage and Administration

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.

Medication Use in Special Populations

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.

Drug Overdose

There is currently no specific antidote for overdose. Symptomatic and supportive treatment should be administered in case of drug overdose.

Storage Conditions

Store at room temperature between 20°C and 25°C; short-term storage within the range of 15°C to 30°C is permitted.

Pharmacokinetics

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