NEW YORK – Novartis said Wednesday that Tabrecta (capmatinib) is now approved in Canada for patients with locally advanced, unresectable or metastatic non-small cell lung cancer with MET exon 14 skipping alterations.
Regulator Health Canada decided to approve the drug based on a Phase II single-arm study (GEOMETRY mono-1), which included 100 patients with these alterations who had one or two lines of prior therapy and 60 who were treatment naïve. Among treatment-naïve patients, the overall response rate was 67.9 percent, median duration of response was 12.6 months, and overall survival was 20.8 months. In the previously treated patients, the overall response rate was 40.6 percent, median duration of response was 9.7 months, and overall survival was 13.6 months.
Tabrecta was approved in 2020 in the US and in Japan for this same indication. The US Food and Drug Administration has also approved two companion diagnostics for Tabrecta to identify eligible patients: Foundation Medicine's tissue-based FoundationOne CDx and FoundationOne Liquid CDx. The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval for Tabrecta in April for previously treated NSCLC patients with METex14 skipping alterations.
"Patients who have been diagnosed with this type of cancer in the past often have had limited options available to them in their treatment journey," Shem Singh, executive director of Lung Cancer Canada, said in a statement. "Knowing more about the molecular makeup of the tumour, and what mutation is driving the cancer, along with newer treatment options like Tabrecta, will enable healthcare teams to better support patients in their treatment journey."