By Fineline Cube 
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to sunvozertinib (trade name: Zegfrovy). The drug is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, who have progressed on or after platinum-based chemotherapy.
Sunvozertinib: Mechanism and Advantages
Sunvozertinib is an oral, irreversible, and highly selective EGFR tyrosine kinase inhibitor (TKI) targeting multiple EGFR mutation subtypes. It addresses an unmet medical need that has persisted for nearly two decades.
Global Approval and Reimbursement
The drug was approved in China under priority review in August 2023. Within its first year of approval, it was included in China’s National Reimbursement Drug List (NRDL). Sunvozertinib is currently the only approved and reimbursed standard therapy for EGFR exon20ins NSCLC in second-line or later settings.-Fineline Info & Tech