Home Takeda's Mobocertinib Succinate Capsules Granted Conditional Approval by China's NMPA for EGFR Exon 20 Insertion-Mutated NSCLC

Takeda's Mobocertinib Succinate Capsules Granted Conditional Approval by China's NMPA for EGFR Exon 20 Insertion-Mutated NSCLC

Jan 11, 2023 16:27 CST Updated 16:27
Takeda

Biopharmaceutical Manufacturer

China's National Medical Products Administration (NMPA) announced on January 11 that recently, the NMPA has granted conditional approval for the marketing of Takeda Pharmaceutical Company Limited’s innovative drug Mobocertinib Succinate Capsules (brand name: Exkivity) through a priority review and approval process. This drug is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed during or after platinum-based chemotherapy and carry epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Mobocertinib is an irreversible tyrosine kinase inhibitor targeting EGFR exon 20 insertion mutations. The approval of this drug provides a new treatment option for patients with advanced non-small cell lung cancer who are positive for EGFR exon 20 insertion mutations.