China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This novel targeted therapy is now approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor 20 exon insertion (EGFR Exon20ins) mutation in patients who have previously been treated with platinum chemotherapy or are intolerant of platinum.
Sunvozertinib: A Breakthrough Therapy with BTD Status in China and the US
Sunvozertinib is the first and only home-grown Category 1 drug with breakthrough therapy designation (BTD) statuses in both China and the US, as well as priority review status in China. This approval marks a significant milestone in the treatment of NSCLC, particularly for patients with EGFR Exon20ins mutations who have limited treatment options.
Phase II WU-KONG6 Study Supports Approval
The approval is supported by the single-arm, multi-center Phase II regulatory WU-KONG6 study, which demonstrated the efficacy and safety of sunvozertinib. In the study, 97 patients receiving sunvozertinib showed an objective response rate (ORR) confirmed by an independent review committee (IRC) of 60.8%. The safety profile was found to be similar to that of traditional EGFR tyrosine kinase inhibitors (TKIs), and the drug exhibited good overall tolerability, allowing for clinical management and restoration.-Fineline Info & Tech
