Sunvozertinib: First Approval

Declarations Funding The preparation of this review was not supported by any external funding. Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sohita Dhillon is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content. Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable. Additional information about this Adis Drug Review can be found here. Abstract 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 intolerable to, platinum-based chemotherapy. Sunvozertinib was granted conditional approval based on 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. This article summarizes the milestones in the development of sunvozertinib leading to this first approval for metastatic NSCLC with EGFR exon20ins. © Springer Nature Switzerland AG 2023