# Sunvozertinib

Source: https://onco.cc/drugs/sunvozertinib/  
OnCo record `sunvozertinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An oral drug for EGFR exon 20 insertion lung cancer that succeeded where mobocertinib failed; approved in China (2023) and the US (2025).

## Summary

Sunvozertinib is a covalent EGFR tyrosine kinase inhibitor selective for exon 20 insertions and other uncommon EGFR mutations, with wild-type sparing and CNS penetration. Developed by Dizal, it is used in locally advanced or metastatic NSCLC with EGFR exon 20 insertions after platinum chemotherapy. The WU-KONG1B study reported response rates of about 45 to 50% after platinum, including intracranial responses, and supported approval in China in 2023 and FDA accelerated approval in July 2025. The WU-KONG28 phase 3 trial versus platinum-pemetrexed in the first line has reported positive progression-free survival. Diarrhoea, rash and raised creatine phosphokinase are the main side effects. Sunvozertinib succeeded where mobocertinib failed and gives exon 20 patients an oral option alongside amivantamab.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-08
- Tags: gap-fill
- Brand: Zegfrovy
- Code: DZD9008
- Modality: Small-molecule EGFR exon 20 insertion TKI (irreversible)
- Mechanism: Covalent inhibitor selective for EGFR exon 20 insertions and other uncommon mutations with wild-type sparing and CNS penetration.
- Approvals: CN 2023: EGFR exon 20 insertion NSCLC after platinum; US 2025: Locally advanced/metastatic NSCLC with EGFR exon 20 insertions after platinum

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Sunvozertinib
- FDA novel approvals 2025: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025

## Connected records

- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- companies: [Dizal Pharmaceutical](https://onco.cc/companies/dizal/)
- terms: [EGFR exon 20 insertion](https://onco.cc/terms/egfr-exon20-insertion/), [EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M)](https://onco.cc/terms/egfr-mutation-subtypes/)
- trials: [A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Ins](https://onco.cc/trials/nct07182682/), [A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21)](https://onco.cc/trials/nct06295432/), [A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)](https://onco.cc/trials/nct05668988/), [Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)](https://onco.cc/trials/nct03974022/), [DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)](https://onco.cc/trials/nct06276283/), [Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC](https://onco.cc/trials/nct06864624/), [Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)](https://onco.cc/trials/nct07079475/), [Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)](https://onco.cc/trials/nct05712902/)
- biomarkers: [EGFR exon 20 insertion](https://onco.cc/biomarkers/egfr-exon-20-insertion/)
- pathways: [Non-small cell lung cancer (KEGG map)](https://onco.cc/pathways/nsclc-signalling/)

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