Lazertinib is an oral kinase inhibitor that received its first approval in the United States in 2024. In combination with Amivantamab, another medicinal product, it provides a novel treatment option for patients with non-small cell lung cancer (NSCLC).

What are the Indications for Lazertinib?

Core Indication

Lazertinib, in combination with Amivantamab, is indicated for use in patients confirmed by a test approved by the U.S. Food and Drug Administration (FDA).

Patient Selection Key Points

(1) Target patient population: This therapeutic regimen is indicated for previously untreated adult patients with advanced NSCLC harboring the aforementioned specific epidermal growth factor receptor (EGFR) mutations.(2) Testing requirement: EGFR mutation status must be confirmed by an FDA-approved test prior to treatment initiation. If no mutation is detected by plasma testing, tumor tissue testing should be performed.

Dosage Form, Strength and Appearance of Lazertinib

Dosage Form, Strength and Appearance

(1) 80 mg tablet: This medicinal product is a yellow, oval, film-coated tablet, debossed with "LZ" on one side and "80" on the other side. Each tablet contains lazertinib mesylate monohydrate equivalent to 80 mg of lazertinib free base.(2) 240 mg tablet: This medicinal product is a reddish-purple, oval, film-coated tablet, debossed with "LZ" on one side and "240" on the other side. Each tablet contains lazertinib mesylate monohydrate equivalent to 240 mg of lazertinib free base.

Administration Method

(1) The recommended dosage is 240 mg orally once daily (equivalent to one 240 mg tablet), which may be taken with or without food.(2) Tablets should be swallowed whole and must not be crushed, split or chewed.(3) If Amivantamab is also administered on the same day, Lazertinib may be taken at any time prior to the administration of Amivantamab.(4) Treatment should be continued until disease progression or unacceptable toxicity occurs.

Storage Conditions for Lazertinib

Storage Requirements

(1) Recommended storage temperature: Store at room temperature between 20°C and 25°C (68°F and 77°F).(2) Permissible temperature excursion: A temporary temperature range of 15°C to 30°C (59°F to 86°F) is allowed for short-term carrying during travel.

Important Storage Precautions

(1) Retain the medicinal product in the original packaging bottle to protect it from light and moisture.(2) Store the medicinal product in a place out of the reach and sight of children to prevent accidental ingestion.(3) Do not use the medicinal product after the expiration date printed on the package.