Approval status and latest clinical progress of capmatinib (Touradda) at home and abroad

Capmatinib (trade name Tabrecta) is a selective MET inhibitor, mainly targeting non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping mutations. 2020yearMaymonth, the United StatesFDA base Accelerated approval was granted on GEOMETRY-mono-1 study data and converted to regular approval in 2022. Since then, Japan, Europe and other countries and regions have also been approved. The National Medical Products Administration of China (NMPA) has officially approved the marketing of capmatinib in 2024, providing domestic patients with a new precision treatment option.

Capmatinib blocks abnormal proliferation of tumor cells by targeting the MET signaling pathway. In the clinical study of GEOMETRY-mono-1, the objective response rate (ORR) of treatment-naïve patients reached approximately 68%. The progression-free survival (PFS) is more than one year; the ORR of patients who have received previous treatment is about 44% and also shows significant efficacy. In addition, capmatinib can penetrate the blood-brain barrier and is also effective in patients with brain metastases. This feature gives it an advantage in clinical application.

Currently, researchers are exploring the application of capmatinib in earlier-stage non-small cell lung cancer, including neoadjuvant and adjuvant treatment options, in order to delay disease progression. At the same time, phase I/Ib trials are evaluating its potential in combination with other targeted drugs such as MEK inhibitors, aiming to further improve efficacy and overcome resistance issues. Some studies are also focusing on its application prospects in different tumor types and expanding the scope of indications.

Overall, capmatinib, as the first targeted drug targeting MET exon 14 mutations, has changed the treatment landscape for this type of patients. With the domestic launch, more patients can obtain standardized treatment locally and avoid relying on overseas channels. In the future, with the accumulation of more clinical data and the maturity of combination treatment strategies, capmatinib is expected to further expand its application scenarios for METRelevant mutations provide more durable and safe therapeutic benefits to lung cancer patients.

Reference link:https://www.drugs.com