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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Friday, August 12, 2022
On August 10, the U.S. Food and Drug Administration (FDA) granted regular approval to the MET tyrosine kinase inhibitor capmatinib (Tabrecta) for adults with metastatic non–small cell lung cancer (NSCLC) whose tumors have a mutation leading to MET exon 14 skipping, as detected by an FDA-approved test. The recommended dose of capmatinib is 400 mg orally twice daily with or without food.
In May 2020, capmatinib was previously granted accelerated approval for the same indication. The accelerated approval was based on the initial overall response rate and the duration of response in the GEOMETRY mono-1 trial (ClinicalTrials.gov identifier NCT02414139), a multicenter, nonrandomized, open-label, multicohort study. The conversion to regular approval was based on data from an additional 63 patients, as well as an additional 22 months of follow- up to assess the durability of response and to verify the clinical benefit.
Efficacy was demonstrated in 160 patients with metastatic NSCLC with a mutation leading to MET exon 14 skipping. Patients received capmatinib at 400 mg orally twice daily until disease progression or unacceptable toxicity. Among 60 treatment-naive patients, the overall response rate was 68% (95% confidence interval [CI] = 55%–80%), with a duration of response of 16.6 months (95% CI = 8.4–22.1 months). Among 100 previously treated patients, the overall response rate was 44% (95% CI = 34%–54%), with a duration of response of 9.7 months (95% CI = 5.6–13 months).
The median age of patients was 71 years. Selected demographics were reported as follows: 61% were female, 77% were White, 61% never smoked, 83% had adenocarcinoma, and 16% had central nervous system metastases.
The most common adverse reactions (≥ 20%) reported with capmatinib were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.
U.S. Food and Drug Administration
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