FDA approves Tabrecta for certain patients with metastatic NSCLC
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The FDA granted accelerated approval to capmatinib for treatment of certain patients with metastatic non-small cell lung cancer.
The approval applies to use of capmatinib (Tabrecta, Novartis) — an oral kinase inhibitor that targets MET — for adults whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test. The agent can be used as first-line therapy or by patients who received prior therapy, regardless of treatment type.
The FDA also approved FoundationOne CDx (Foundation Medicine) as a companion diagnostic for capmatinib to help detect mutations that lead to MET exon 14 skipping in tumor tissue.
MET exon 14 skipping occurs in approximately 3% to 4% of newly diagnosed metastatic NSCLC cases in the United States, equating to an estimated 4,000 to 5,000 patients per year.
The FDA based the approval of capmatinib on results of the phase 2, nonrandomized, multicohort GEOMETRY study, which included adults with EGFR wild-type metastatic NSCLC.
One cohort included 97 adults whose tumors harbored mutations that lead to MET exon 14 skipping. Most patients (n = 69) had undergone prior treatment.
Patients received capmatinib dosed at 400 mg twice-daily. Overall response rate based on blinded independent review committee assessment served as the major efficacy outcome. Duration of response served as an additional efficacy outcome.
Researchers reported confirmed ORRs of 68% (95% CI, 48-84) among treatment-naive patients and 41% (95% CI, 29-53) among those who received prior treatment.
Median duration of response was 12.6 months (95% CI, 5.5-25.3) in the treatment-naive group and 9.7 months (95% CI, 5.5-13) among previously treated patients.
The most common treatment-related adverse events included peripheral edema, nausea, fatigue, vomiting, dyspnea and decreased appetite.
“Non-small cell lung cancer is a complex disease, with many different possible mutations that may encourage the cancer’s growth,” lead investigator Juergen Wolf, MD, of Center for Integrated Oncology at University Hospital Cologne, said in a Novartis-issued press release. “MET exon 14 skipping is a known oncogenic driver. With today’s decision by the FDA, we can now test for and treat this challenging form of lung cancer with a targeted therapy, offering new hope for patients with NSCLC harboring this type of mutation.”
The FDA previously granted breakthrough therapy designation to capmatinib for this indication.