Capmatinib (Tabrecta) is a highly selective MET kinase inhibitor targeting specific gene mutations, developed by Novartis and approved for marketing by the U.S. FDA in 2020.

What Are the Indications for Capmatinib (Tabrecta)?

Main Indications

(1) Capmatinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutation.

(2) For this indication, the mutation status in tumor tissue or plasma must be confirmed by an FDA-approved testing method.

(3) If no mutation is detected in plasma, supplementary tumor tissue testing is recommended when conditions permit.

Pharmacological Action

(1) MET exon 14 skipping mutation leads to the deletion of the regulatory domain, which in turn causes persistent activation of downstream MET signaling.

(2) By blocking MET phosphorylation and downstream proliferation signals, capmatinib has demonstrated significant inhibitory effects on MET-dependent tumor cells in preclinical studies.

Dosage Form, Specification and Characteristic of Capmatinib (Tabrecta)

Dosage Strengths

(1) 150mg tablet: Light brownish-orange oval film-coated tablet with beveled edges, no score line, marked with "DU" on one side and "NVR" logo on the other.

(2) 200mg tablet: Yellow oval film-coated tablet with beveled edges, no score line, marked with "LO" on one side and "NVR" logo on the other.

(3) All tablets must be swallowed whole; do not break, crush or chew them.

Composition

(1) The active ingredient of the tablet is capmatinib (present as capmatinib hydrochloride dihydrate).

(2) Excipients include colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, etc. The film coating layer contains pharmaceutical coating materials such as iron oxide, hypromellose, and polyethylene glycol.

Storage Conditions for Capmatinib (Tabrecta)

Storage Environment

(1) It should be stored with the desiccant in the original packaging.

(2) Store at 20°C-25°C (68°F-77°F), with a temporary allowable range of 15°C-30°C (59°F-86°F).

(3) Strictly protect from light and moisture, and avoid direct ultraviolet radiation.

Validity Period and Post-Opening Handling

(1) After the first opening of the bottle, the remaining medicine must be used up within 6 weeks; discard any unused portion after the time limit.

(2) The package should be sealed immediately after daily use to avoid the impact of humidity on the stability of the tablets.