Global marketing status of capmatinib and its application in the treatment of NSCLC

Capmatinib (Capmatinib), an innovative drug developed by Novartis, has been launched globally under the brand name Tabrecta. A major milestone in its development occurred in May 2020, when it received accelerated approval from the U.S. Food and Drug Administration (FDA) specifically for patients with non-small cell lung cancer (NSCLC) with mesenchymal epithelial transition (MET) exon 14 skipping caused by tumor mutations. Of note, the presence of this mutation must be confirmed by an FDA-approved test, such as the FoundationOne CDx test produced by Foundation Medicine, which also approved this new treatment indication on the same day.

In June 2022, Health Canada also granted market access to this drug. Although the pivotal study did not directly compare capmatinib with other cancer treatments, the results clearly demonstrate the drug's effectiveness in previously treated patients with advanced NSCLC who have the METex14 skipping mutation. Its controllable side effects further enhance its therapeutic advantages. For this reason, the European Medicines Agency (EMA) officially approved the medical use of capmatinib in the EU in September 2022 after assessing the risks and benefits.

To date, capmatinib has been approved in many countries and regions, including the European Union, the United States, Switzerland and Japan, and has become the first-choice targeted therapy for patients with advanced NSCLC targetingMETex14 skipping mutations. Unfortunately, the original drug capmatinib is not currently on the market in China. If domestic patients need this drug, they still need to purchase it through overseas channels. It is hoped that this innovative drug can enter the domestic market as soon as possible in the future and benefit more patients.