Biopharmaceutical company Dizal (SSE:688192) announced on Friday that it has submitted a New Drug Application (NDA) to the US FDA for sunvozertinib, targeting locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (exon20ins) post-platinum-based chemotherapy.

Data from the pivotal WU-KONG1 Part B study, featured at the 2024 ASCO Annual Meeting, supports the application, highlighting significant objective response rates and a manageable safety profile.

Sunvozertinib, an oral EGFR inhibitor, previously received accelerated approval in China and Breakthrough Therapy Designations from both the US FDA and China CDE. Demonstrating efficacy across various EGFR exon20ins subtypes and brain metastasis cases, the drug addresses a key unmet need, improving outcomes for patients with poorer prognosis.