NEW YORK – Novartis said on Monday that the Japanese Ministry of Health, Labor, and Welfare has approved the MET inhibitor capmatinib (Novartis' Tabrecta) for advanced or recurrent unresectable non-small cell lung cancer patients whose tumors have a mutation that leads to MET exon 14 skipping. The agent is approved for both treatment-naïve and previously treated patients.
Capmatinib was first discovered by Incyte and was later licensed to Novartis in 2009. Although Novartis owns exclusive worldwide development and commercialization rights to the drug, Incyte is eligible to receive between 12 percent and 14 percent of the royalties based on capmatinib's global sales.
The Japanese approval follows capmatinib's accelerated approval in May by the US Food and Drug Administration for the same indication. At the time, the agency simultaneously approved Foundation Medicine's FoundationOne CDx as a companion diagnostic for the drug. Later that same month, Japanese regulators likewise granted approval to FoundationOne CDx to aid in the detection of MET exon 14 skipping mutations in tumor tissue.
Both of the approvals were based on results from the Phase II GEOMETRY mono-1 study, a multi-center, non-randomized trial that evaluated overall response rate with capmatinib in both treatment-naive and previously treated patients. A blinded independent review committee confirmed an overall response rate of 68 percent among treatment -naïve patients and 41 percent among previously treated patients. The median duration of response was 12.6 months and 9.7 months, respectively.
"Today's approval reinforces the potential benefit this new MET inhibitor can bring to thousands of patients diagnosed in Japan each year and is a positive step in our journey to transform the lives of patients with lung cancer," Brian Gladsden, president of Novartis Oncology, Japan, said in a statement.