NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use on Friday issued a positive opinion for Novartis' Tabrecta (capmatinib) as a therapy for previously treated, advanced non-small cell lung cancer patients whose tumors harbor alterations leading to MET exon 14 skipping.
CHMP specified that patients eligible for the MET inhibitor should have already received immunotherapy or platinum-based chemotherapy or both. The European Commission will now review CHMP's opinion and decide whether to approve Tabrecta for this indication.
The committee recommended that the European Commission approve Tabrecta for this patient population based on the results of the Phase II GEOMETRY mono-1 study, in which the overall response rate among patients receiving second-line treatment was 51.6 percent. Among all previously treated NSCLC patients with METex14 skipping, the response rate was 44 percent.
In 2020, the US Food and Drug Administration approved Tabrecta for metastatic NSCLC patients with mutations leading to METex14 skipping but did not specify that patients be previously treated. The FDA also approved Foundation Medicine's FoundationOne CDx next-generation sequencing test as a companion diagnostic to determine METex14 skipping. The following year, the agency approved Foundation Medicine's liquid biopsy test as a companion diagnostic for the drug, too.
Japanese regulators also approved Tabrecta in 2020 for both previously treated and treatment-naïve NSCLC with the biomarker.
"If approved by the European Commission, new targeted therapies like Tabrecta — supported by early and broad molecular testing of patients' tumors — can better guide treatment decisions and ensure patients receive the appropriate therapy for their cancer," Juergen Wolf of the Center for Integrated Oncology within University Hospital Cologne, Germany, and lead investigator on the GEOMETRY mono-1 trial, said in a statement.