Mobocertinib (Exkivity) is a new-generation EGFR inhibitor that provides an important treatment option for patients with specific mutations. As an innovative drug approved in the United States in 2021, it specifically targets EGFR exon 20 insertion mutations, offering a new therapeutic choice for previously treated patients.

What Are the Indications for Mobocertinib (Exkivity)?

Primary Indications

Mobocertinib is mainly indicated for the treatment of adult patients with EGFR exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

It is particularly suitable for patients who have experienced disease progression during or after platinum-based chemotherapy.

This indication is granted under accelerated approval based on overall response rate and duration of response, and subsequent confirmatory trials may be required to verify clinical benefit.

Mutation specificity: It is only effective against EGFR exon 20 insertion mutations, and mutation status must be confirmed by an FDA-approved testing method before use.

Pharmacological Action

Mobocertinib belongs to the class of kinase inhibitor drugs.

Its pharmacological effect lies in irreversibly binding to and inhibiting EGFR exon 20 insertion mutations at concentrations lower than those required to inhibit wild-type EGFR.

After entering the body, the drug is converted into two pharmacologically active metabolites, AP32960 and AP32914, which have inhibitory properties similar to the parent drug.

In addition to its primary target, it can also inhibit other members of the EGFR family and certain specific kinases.

Dosage Form, Strength and Appearance of Mobocertinib (Exkivity)

Dosage Strength

Mobocertinib is supplied as capsules, with each capsule containing 40 mg of mobocertinib (equivalent to 48.06 mg of mobocertinib succinate).

Appearance and Characteristics

Appearance: The capsules are white and size 2.

Markings: The capsule cap is printed with "MB788" and the capsule body with "40mg", both in black ink.

Composition: The capsule shell contains gelatin and titanium dioxide, and the printing ink contains shellac, dehydrated alcohol, isopropanol, butanol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.

The capsule contains no inactive ingredients, and the contents should not be opened, chewed, or dissolved; the capsule must be swallowed whole.

Storage Method for Mobocertinib (Exkivity)

Storage Conditions

Storage temperature: Store at 20°C to 25°C (68°F to 77°F).

Permitted short-term deviation: Short-term storage is allowed in the range of 15°C to 30°C (59°F to 86°F).

Environmental requirements: Store in a dry place, away from direct sunlight and high-temperature, high-humidity environments.

Safety reminder: Keep the drug out of the reach of children to avoid accidental ingestion.