Swiss pharmaceutical titan Novartis has secured marketing approval from China’s National Medical Products Administration (NMPA) for its drug Tabrecta (capmatinib), intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a mesenchymal–epithelial transition (MET) exon 14 skipping mutation, who have not received prior systemic treatment.
This regulatory milestone is underpinned by the global, multi-center GeoMETry mono-1 study and the China-specific GeoMETry-C study. The GeoMETry mono-1 study demonstrated compelling efficacy with an objective response rate (ORR) of 68.3% and a disease control rate (DCR) of 98.3% in advanced NSCLC patients with METex14 skipping mutation, along with a median overall survival (OS) of 25.5 months. The China GeoMETry-C study, as of November 30, 2022, reported an ORR of 53.3% and 60% in first-line METex14 advanced NSCLC patients, aligning with global data, and a noteworthy intracranial complete response rate of 50% in patients with brain metastases. Safety profiles among Chinese patients mirror those of the global patient population.
Capmatinib, an orally administered specific MET receptor tyrosine kinase inhibitor (TKI), potently inhibits MET-mediated phosphorylation of MET and downstream signaling proteins, thereby impeding tumor cell proliferation and migration, and effectively inducing cellular apoptosis. This showcases its robust anti-tumor activity. Afore the official approval, capmatinib was included in the second batch of urgently needed drugs and devices for import from Hong Kong and Macau in the Greater Bay Area in early 2022, seeing clinical application in the special medical institution within the Lecheng pilot zone.- Flcube.com
