Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for its Category 1 product, glumetinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET 14 exon mutation.
Glumetinib’s Development and Efficacy
Co-developed by Haihe Pharma and the Chinese Academy of Sciences’ Shanghai Institute of Materia Medica (SIMM), glumetinib has demonstrated preliminary efficacy in MET-positive advanced NSCLC. The drug has shown a good pharmacokinetics safety and tolerability profile in clinical studies. Glumetinib received approval for use in locally advanced or metastatic NSCLC with MET14 exon skipping in China in March this year.
Japan Filing Supported by Pivotal Phase II Study Data
The filing in Japan is supported by the efficacy and safety data from the pivotal SCC244-108 Phase II study, which underpinned China’s marketing filing. Glumetinib has been shown to be highly efficacious with controllable safety in both naïve and treated patients with locally advanced or metastatic non-small cell lung cancer harboring the METex14 mutation.-Fineline Info & Tech
