The Food and Drug Administration (FDA) has granted regular approval to Tabrecta (capmatinib) for the treatment of adults 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 was previously granted accelerated approval for this indication in May 2020 based on initial overall response rate (ORR) and duration of response (DOR) in the phase 2 GEOMETRY mono-1 study (ClinicalTrials.gov Identifier: NCT02414139). The conversion to regular approval was based on data from an additional 63 adults with metastatic NSCLC with confirmed MET exon 14 skipping, as well as 22 months of follow-up time. Patients received Tabrecta 400mg orally twice daily until disease progression or unacceptable toxicity.
Results demonstrated that among 60 treatment-naïve patients, the ORR was 68% (95% CI, 55-80), with 5% of patients achieving complete response (CR) and 63% of patients achieving partial response (PR). The median duration of response (DOR) was 16.6 months (95% CI, 8.4-22.1); 49% of patients had a DOR lasting at least 12 months.
Among 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 had a DOR lasting at least 12 months.
The most common adverse reactions reported with Tabrecta were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.
Tabrecta is supplied as 150mg and 200mg tablets in 56-count bottles.
- FDA approves capmatinib for metastatic non-small cell lung cancer. News release. US Food and Drug Administration. Accessed August 11, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capmatinib-metastatic-non-small-cell-lung-cancer/
- Tabrecta. Package insert. Novartis Pharmaceuticals; 2022. Accessed August 11, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s004lbl.pdf