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FDA Approves Novartis' Capmatinib, Foundation Medicine CDx for Metastatic NSCLC

NEW YORK – The US Food and Drug Administration on Wednesday approved capmatinib (Novartis' Tabrecta) for treatment of patients with metastatic non-small cell lung cancer.

The agency also approved Foundation Medicine's FoundationOne CDx assay, a broad comprehensive genomic profiling test for solid tumors, as a companion diagnostic for the drug. A companion diagnostic for capmatinib with Foundation's liquid biopsy test is also in development, Foundation said.

Capmatinib is an oral mesenchymal-epithelial transition inhibitor for adult patients with metastatic NSCLC whose tumors have a mutation that leads to MET exon 14 skipping. It is approved for first-line and previously treated patients, and is the first FDA-approved treatment for adult patients with metastatic NSCLC with the mutation that leads to METex14. 

Novartis has exclusive worldwide development and commercialization rights to the drug, which was discovered by Incyte and licensed in 2009, and its approval triggers $70 million in milestone payments to Incyte.

The drug previously received breakthrough therapy designation from the FDA, and this indication is approved under accelerated approval based on overall response rate and duration of response, Novartis said in a statement.

The approval is based on results from the GEOMETRY mono-1 Phase II multicenter study, which had a confirmed overall response rate of 68 percent and 41 percent among treatment-naïve and previously treated patients, respectively. 

"Having a therapy that targets the recognized oncogenic driver will provide a much-needed treatment option for patients with METex14 NSCLC who currently have limited treatment options," Incyte CMO Steven Stein said in a statement.