Zongertinib is a novel kinase inhibitor recently granted accelerated approval by the U.S. FDA. As a targeted therapy for specific patients with non-small cell lung cancer (NSCLC), its key information—including indication, specification, physical properties, and storage method—is of great importance for clinical use.

Indication of Zongertinib

Core Indication

Zongertinib is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).

The tumor must be confirmed to harbor activating mutations in the tyrosine kinase domain of HER2 (ERBB2) via an FDA-approved detection method.

The patient has previously received systemic therapy.

Usage Limitations

It is not indicated for patients without HER2 mutation testing or for those with squamous NSCLC.

Eligible patients must be screened through a companion diagnostic test (e.g., Oncomine™ Dx Target Test).

Specification and Physical Properties of Zongertinib

Specification and Physical Characteristics

Dosage Form: Oral film-coated tablets. They are oval-shaped, biconvex tablets for ease of swallowing.

Strength/Content: Each tablet contains 60 mg of zongertinib—this is the only available strength of the drug currently.

Appearance Features

Color: Yellow.

Imprint: One side is imprinted with "L6", and the other side bears the Boehringer Ingelheim company logo.

Surface Property: Film-coated with a smooth and uniform surface.

Formulation Composition

Active Ingredient: Each tablet contains 60 mg of zongertinib.

Excipients: Including colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, mannitol, microcrystalline cellulose, and sodium stearyl fumarate.

Coating Ingredients: Including yellow iron oxide, glycerol monocaprylate and dicaprylate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.

Storage Method of Zongertinib

Temperature Control

Ideal Storage Temperature: 20°C to 25°C (68°F to 77°F).

Permitted Temporary Deviation: 15°C to 30°C (59°F to 86°F).

Packaging Features

Packaged in child-resistant bottles.

Each bottle is equipped with two silica gel desiccants to control humidity.

Commercial packaging consists of a carton containing one bottle with 60 tablets.

Other Precautions

Keep the original packaging intact and protect from moisture.

Store away from direct sunlight and heat sources.

Keep out of the reach of children.

Do not store the medication in humid environments such as bathrooms.