Is capmatinib on the market?

In May 2020, Capmatinib, produced by Novartis and marketed under the brand name Tabrecta, received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of non-small cell lung cancer (NSCLC) in patients with tumor mutations that cause mesenchymal epithelial transition (MET) exon 14 skipping . The presence of the mutation must be confirmed by an FDA-approved test, such as the FoundationOne CDx test (manufactured by Foundation Medicine), which the FDA approved for this indication on the same day. Because this indication was granted under accelerated approval, its continued approval is dependent on verification of capmatinib's efficacy in confirmatory trials. Health Canada approved capmatinib in June 2022.

While the main study did not compare capmatinib to another cancer treatment, it showed that the drug was effective in previously treated patients with non-small cell lung cancer whose cancer was advanced and who had the "METex14 skipping" mutation. The side effects of capmatinib are considered manageable. Therefore, the European Medicines Agency decided that the benefits of capmatinib outweighed its risks, and it was approved for medical use in the EU in September 2022.

Capmatinib has been approved in several countries, including the European Union, the United States, Switzerland and Japan. This is the first-choice targeted therapy drug for patients with advanced non-small cell lung cancer worldwide. The condition of these patients has changed, resulting in a sudden increase in METex14 worldwide. However, as of now, the original drug capmatinib has not been launched in China, and domestic patients in need can only purchase this drug through relevant overseas channels. For more information on overseas drug prices and related information, please consult Yaode Medical Consultants.