General Information

Tabrecta (capmatinib) is a kinase inhibitor that targets MET.

Tabrecta is specifically indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA approved test. 

Tabrecta is supplied as a tablet for oral administration. The recommended dosage is 400 mg orally twice daily with or without food. Tabrecta tablets should be swallowed whole. Do not break, crush or chew the tablets.  If a patient misses or vomits a dose, instruct the patient not to make up the dose, but to take the next dose at its scheduled time. 

FDA Approval

Tabrecta for EGFR wild-type, metastatic NSCLC was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). 

The FDA approval of Tabrecta was based on results from the pivotal GEOMETRY mono-1 Phase II multi-center, non-randomized, open-label, multi-cohort study in adult patients with EGFR wild-type, metastatic NSCLC as measured by ORR.The trial evaluated 97 adult patients with metastatic NSCLC harboring mutations that lead to METex14 (centrally confirmed) who were assigned to Cohorts 4 (n=69, previously treated patients) or 5b (n=28, treatment-naive), and received capmatinib tablets 400 mg orally twice daily. n the METex14 population (n=97), the confirmed overall response rate was 68% and 41% among treatment-naive (n=28) and previously treated patients (n=69), respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. In patients taking Tabrecta, the study also demonstrated a median duration of response of 12.6 months in treatment-naive patients (19 responders) and 9.7 months in previously treated patients (28 responders).

Side Effects

Adverse effects associated with the use of Tabrecta may include, but are not limited to, the following:

• peripheral edema
• nausea
• fatigue
• vomiting
• dyspnea
• decreased appetite

Mechanism of Action

Tabrecta (capmatinib) is a kinase inhibitor that targets MET, including the mutant variant produced by exon 14 skipping. MET exon 14 skipping results in a protein with a missing regulatory domain that reduces its negative regulation leading to increased downstream MET signaling.

Additional Information

For additional information regarding Tabrecta or MET mutated, EGFR wild-type, metastatic NSCL, please visit the Tabrecta website.