Zongertinib is a novel kinase inhibitor recently granted accelerated approval by the U.S. FDA. As a targeted therapeutic drug for specific patients with non-small cell lung cancer (NSCLC), key information such as its indications, specifications, characteristics, and storage methods is of great importance for clinical use.

Indications of Zongertinib

Core Indications

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

The tumor harbors activating mutations in the tyrosine kinase domain of HER2 (ERBB2), confirmed by an FDA-approved detection method.

The patient has received prior systemic therapy.

Use Restrictions

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

Eligible populations must be selected through companion diagnostics (e.g., Oncomine™ Dx Target Test).

Specifications and Characteristics of Zongertinib

Specification and Characteristic Features

Dosage Form: Oral film-coated tablets, which are oval biconvex tablets for ease of swallowing by patients.

Specification and Content: Each tablet contains 60mg of zongertinib—this is currently the only specification of the drug.

Appearance Features

Color: Yellow.

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

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

Formulation Composition

Active Ingredient: Each tablet contains 60mg of zongertinib.

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

Coating Ingredients: Include yellow iron oxide, glyceryl monocaprylate and caprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.

Storage Methods of Zongertinib

Temperature Control

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

Allowable Temporary Deviation Range: 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.

The commercial packaging is a carton containing one bottle with 60 tablets.

Other Precautions

Keep the original packaging intact and protect from moisture.

Keep away from direct sunlight and heat sources.

Store out of the reach of children.

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