Sunvozertinib FDA Approval Status
Last updated by Judith Stewart, BPharm on Nov 18, 2024.
FDA Approved: No
Generic name: sunvozertinib
Company: Dizal
Treatment for: Non Small Cell Lung Cancer
Sunvozertinib is an irreversible EGFR inhibitor in development for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations.
- Roughly 2%-4% of NSCLC patients have EGFR exon20ins mutations which are difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity.
- Sunvozertinib has a molecular structure that enables it to overcome the inherent difficulties of targeting EGFR exon20ins mutations, offering improved efficacy, safety, and ease of administration.
- A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of sunvozertinib for the treatment of locally advanced or metastatic NSCLC patients with EGFR exon20ins mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The NDA submission was supported by results from the WU-KONG1 Part B study showing that sunvozertinib met the primary endpoint by demonstrating statistically significant and clinically meaningful objective response rate (ORR), as assessed by an independent review committee (IRC), while maintaining a manageable safety profile.
Development timeline for sunvozertinib
Further information
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