In what year was capmatinib officially launched?

Capmatinib (trade name Tabrecta) is an oral, highly selective METtyrosine kinase inhibitor, specifically used to treat patients with METNSCLC) with n>exon14skipping (METex14) mutations. On 2020May June , the U.S. Food and Drug Administration (FDA) approved the marketing of capmatinib through the accelerated approval process, becoming the first targeted therapy drug targeting this specific gene mutation.

This approval is based on the results of the pivotal II phase clinical studyGEOMETRY mono-1. In this study, 97 patients with advanced NSCLC carrying METex14 mutations were treated with capmatinib. The results showed that the objective response rate (ORR) of treatment-naïve patients was 68%, and the median duration of response (DoR) was 12.6 months; the ORR in treated patients was 41%, and the median DoR was 9.7 months. These data suggest that capmatinib exhibits promising efficacy in different treatment settings.

Common adverse reactions of capmatinib include peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. In addition, some patients may develop serious adverse events such as interstitial lung disease, hepatotoxicity, and photosensitivity reactions. Therefore, during treatment with capmatinib, it is recommended that patients regularly monitor lung and liver function and take sun protection measures to reduce the risk of photosensitivity reactions.

Currently, capmatinib has been approved for marketing in the United States, but has not yet been launched in mainland China. For NSCLC carrying METex14 mutationspatients, capmatinib provides a new targeted treatment option that is expected to improve the prognosis of these patients. As more clinical studies are conducted, the indications and scope of use of capmatinib may be further expanded, bringing benefits to more patients.

Reference materials:https://www.novartis.com/our-products/pipeline/capmatinib