FDA grants Tabrecta regular approval for certain patients with non-small cell lung cancer
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The FDA approved capmatinib for treatment of certain adults with metastatic non-small cell lung cancer.
The approval applies to patients whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected through an FDA-approved test.
Capmatinib (Tabrecta, Novartis) — an oral kinase inhibitor that targets MET — received accelerated approval in 2020 for the same indication based on initial overall response rate and duration of response results of the phase 2, nonrandomized, multicohort GEOMETRY mono-1 study.
As Healio previously reported, one cohort included 97 adults whose tumors harbored mutations that lead to MET exon 14 skipping. The FDA based the conversion to regular approval on data from an additional 63 patients, as well as an additional 22 months of follow-up to evaluate durability of response and confirm clinical benefit.
Patients had a median age of 71 years (range, 48-90). Most were white (77%), female (61%), never smoked (61%) and had adenocarcinoma (83%). In addition, 16% had central nervous system metastases. Most of those previously treated had received prior platinum-based chemotherapy (86%) and only one prior line of systemic therapy (81%).
Patients received capmatinib dosed at 400 mg twice a day until disease progression or unacceptable toxicity. ORR and duration of response based on blinded independent review committee assessment served as the primary efficacy measures.
Results showed ORRs of 68% (95% CI, 55-80) among treatment-naive patients and 44% (95% CI, 34-54) among those who received prior treatment. Median duration of response was 16.6 months (95% CI, 8.4-22.1) in the treatment-naive group and 9.7 months (95% CI, 5.56-13) among previously treated patients.
The most common treatment-related adverse events included edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough and decreased appetite.
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