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On August 10, 2022, the Food and Drug Administration granted regular approval to capmatinib for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.
Capmatinib was previously granted accelerated approval for the same indication on May 6, 2020, based on the initial overall response rate and duration of response in the GEOMETRY mono-1 trial (NCT02414139), a multicenter, non-randomized, open-label, multi-cohort 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 time to assess the durability of response and verify clinical benefit.
Efficacy was demonstrated in 160 patients with metastatic NSCLC with a mutation leading to MET exon 14 skipping. Patients received capmatinib 400 mg orally twice daily until disease progression or unacceptable toxicity.
The primary efficacy measures were ORR and duration of response (DOR) as determined by a Blinded Independent Review Committee (BIRC). Among 60 treatment-naïve patients, ORR was 68% (95% CI: 55, 80) with a DOR of 16.6 months (95% CI: 8.4, 22.1). Among 100 previously treated patients, ORR was 44% (95% CI: 34, 54) with a DOR of 9.7 months (95% CI: 5.6, 13).
The median age of patients was 71 years (48 to 90). Selected demographics were reported as follows: 61% female, 77% White, 61% never smoked, 83% had adenocarcinoma, and 16% had CNS metastases. Among previously treated patients, 81% received one, 16% received two, and 3% received three prior lines of systemic therapy. Amongst previously treated patients, 86% received prior platinum-based chemotherapy.
The most common adverse reactions (≥20%) in patients were oedema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.
The recommended capmatinib dose is 400 mg orally twice daily with or without food.
View full prescribing information for capmatinib here.
Source: FDA
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