Dizal Pharmaceutical Co., Ltd (SHA: 688192), a Chinese pharmaceutical company, has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for sunvozertinib, a targeted therapy for lung cancer. The company is seeking approval for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), particularly for those who have experienced disease progression on or after platinum-based chemotherapy.
Supporting Evidence from WU-KONG1B Study
The NDA filing is supported by the results of the WU-KONG1B, a multinational pivotal study that evaluated the efficacy and safety of sunvozertinib in relapsed or refractory EGFR exon20ins NSCLC patients. With non-Asian patients comprising over 40% of the total subjects, the study demonstrated sunvozertinib’s primary endpoint, showcasing its potential as a best-in-class therapy with “high efficiency and low toxicity” on a global scale.
Sunvozertinib’s Status in China and the US
In China, sunvozertinib, a next-generation EGFR inhibitor originally discovered by AstraZeneca’s (AZ) China R&D team and later included in the Dizal spin-off, has become the sole standard treatment for EGFR exon20ins NSCLC in the second-line/posterior line setting. The molecule received its first approval in China in August 2023. In the US, sunvozertinib has been granted multiple Breakthrough Therapy Designations (BTDs) by the FDA for the EGFR exon20ins NSCLC indication, covering all lines of treatment.-Fineline Info & Tech
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