Mobocertinib succinate capsules approved for marketing with conditions

Recently, the Class 1 innovative drug mobocertinib succinate capsule (trade name: 安卫力/EXKIVITY) of Takeda Pharmaceutical, Inc. is approved for marketing with conditions through the priority review and approval procedure by China NMPA. This drug is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

Mobocertinib is an irreversible tyrosine kinase inhibitor targeting the EGFR exon 20 insertion mutations. The marketing of this drug provides a new treatment option for patients with advanced NSCLC with EGFR exon 20 insertion mutations.