On August 10, 2022, the U.S. Food and Drug Administration (FDA) announced the granting of standard approval to Tabrecta (carmatinib) for the treatment of adult metastatic non-small cell lung cancer (NSCLC) with a mutation causing mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.
Previous accelerated approval for this indication was based on the initial overall response rate (ORR) and duration of response (DOR) in the phase 2 GEOMETRYmono-1 study (NCT02414139).
The conversion to standard approval is based on data from an additional 63 adult patients with confirmed MET exon 14 skipping metastatic NSCLC followed for 22 months. Patients receive Tabrecta 400 mg orally twice daily until disease progression or unacceptable toxicity.
Results showed that in 60 treatment-naïve patients, the ORR was 68% (95% CI, 55–80), with 5% achieving complete response (CR) and 63% achieving partial response (PR). The median duration of response (DOR) was 16.6 months (95% CI, 8.4–22.1); 49% of patients experienced a DOR lasting at least 12 months.
In 100 previously treated patients, the ORR was 44% (95% CI, 34–54); 44% of patients had a partial response. The median DOR was 9.7 months (95% CI, 5.6–13); 36% of patients experienced a DOR lasting at least 12 months.
The most common adverse reactions to Tabrecta were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.
