Sunvozertinib: First Approval

Sunvozertinib (舒沃哲^®) is an oral, irreversible, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being developed by Dizal Pharmaceuticals (a joint venture company formed by AstraZeneca and the Chinese Future Industry Investment Fund) for the treatment of non-small cell lung cancer (NSCLC). Sunvozertinib has potent activity against EGFR mutations, including EGFR exon 20 insertion (exon20ins), and weak activity against wild-type EGFR. In August 2023, sunvozertinib received its first approval for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon20ins mutations whose disease has progressed on or after, or who are intolerable to, platinum-based chemotherapy. Sunvozertinib was granted conditional approval based on the overall response rates and duration of response in a single-arm phase 2 trial. Its full approval is contingent on results from ongoing confirmatory phase 3 randomized trials. Clinical studies of sunvozertinib are underway in several countries worldwide. This article summarizes the milestones in the development of sunvozertinib leading to this first approval for metastatic NSCLC with EGFR exon20ins.