Dizal (SSE:688192), a China-based biopharmaceutical company involved in developing novel medicines for the treatment of cancer and immunological diseases, announced on Wednesday that the US Food and Drug Administration (FDA) has approved ZEGFROVY (sunvozertinib).

The drug targets adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. It is an oral, irreversible EGFR inhibitor with uniquely designed molecular structure targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity.

ZEGFROVY, which has received Priority Review and Breakthrough Therapy Designation from the FDA, is currently the only approved targeted oral treatment for this specific mutation. The approval is based on results from the pivotal multinational WU-KONG1 Part B study, which showed statistically and clinically meaningful efficacy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

This milestone builds on ZEGFROVY's earlier accelerated approval from the Centre for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in August 2023.