Sunvozertinib

Sunvozertinib
Clinical data
Trade names	舒沃哲, Zegfrovy
Routes of; administration	Oral
ATC code	None;
Legal status
Legal status	US: ℞-only; Rx in China;
Identifiers
	IUPAC name N-[5-[[4-[5-chloro-4-fluoro-2-(2-hydroxypropan-2-yl)anilino]pyrimidin-2-yl]amino]-2-[(3R)-3-(dimethylamino)pyrrolidin-1-yl]-4-methoxyphenyl]prop-2-enamide;
CAS Number	2370013-12-8;
PubChem CID	139377809;
DrugBank	DB18925;
UNII	L1Q2K5JYO8;
KEGG	D12506;
Chemical and physical data
Formula	C29H35ClFN7O3
Molar mass	584.09 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES COC1=CC(N2CC[C@H](C2)N(C)C)=C(NC(=O)C=C)C=C1NC1=NC=CC(NC2=CC(Cl)=C(F)C=C2C(C)(C)O)=N1;

Sunvozertinib is an anti-cancer medication used for the treatment of non-small-cell lung cancer.^[2]^[3] It is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.^[2]^[4]

Sunvozertinib was approved for medical use in the United States in July 2025.^[1]

Medical uses

In the US, sunvozertinib is indicated for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.^[1]

Side effects

The US FDA prescribing information for sunvozertinib includes warnings and precautions for interstitial lung disease/pneumonitis, gastrointestinal adverse reactions, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity.^[1]

History

Sunvozertinib is being developed by Dizal Pharmaceutical.^[5] In China, it was conditionally approved in 2023 for the treatment of NSCLC and full approval is contingent on results of phase 3 clinical trials.^[6] In the United States, it has been designated by the Food and Drug Administration as a breakthrough therapy for patients with locally advanced or metastatic NSCLCs with an EGFR exon 20 insertion mutation.^[7]

Efficacy was evaluated in WU-KONG1B (NCT03974022), a multinational, open-label, dose randomization trial.^[1] Eligible participants had locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations with disease progression on or after platinum-based chemotherapy.^[1] The primary efficacy population was in 85 participants who received sunvozertinib 200 mg orally once daily with food until disease progression or intolerable toxicity.^[1]

The US Food and Drug Administration granted the application for sunvozertinib priority review and breakthrough therapy designations.^[1]

References

^ ^a ^b ^c ^d ^e ^f ^g ^h "FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations". U.S. Food and Drug Administration (FDA). 2 July 2025. Retrieved 7 July 2025. This article incorporates text from this source, which is in the public domain.
^ ^a ^b Wang M, Yang JC, Mitchell PL, Fang J, Camidge DR, Nian W, et al. (2022). "Sunvozertinib, a Selective EGFR Inhibitor for Previously Treated Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations". Cancer Discovery. 12 (7): 1676–1689. doi:10.1158/2159-8290.CD-21-1615. PMC 9262839. PMID 35404393.
^ Wang M, Fan Y, Sun M, Wang Y, Zhao Y, Jin B, et al. (2024). "Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): Single-arm, open-label, multicentre, phase 2 trial". The Lancet Respiratory Medicine. 12 (3): 217–224. doi:10.1016/S2213-2600(23)00379-X. PMID 38101437.{{cite journal}}: CS1 maint: overridden setting (link)
^ Hidetoshi Hayashi (2024). "Sunvozertinib: the next candidate of TKI for NSCLC". The Lancet Respiratory Medicine. 12 (3): 185–186. doi:10.1016/S2213-2600(23)00419-8. PMID 38101435.
^ "ASH: With high tumor response, AstraZeneca spinout Dizal explores FDA path and US partner for PTCL drug". Fierce Biotech. 11 December 2023.
^ Dhillon S (2023). "Sunvozertinib: First Approval". Drugs. 83 (17): 1629–1634. doi:10.1007/s40265-023-01959-5. PMID 37962831.
^ "FDA Grants Breakthrough Therapy Designation to Sunvozertinib in EGFR Exon20+ NSCLC". targetedonc.com. 9 April 2024.

External links

Clinical trial number NCT03974022 for "Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer with EGFR or HER2 Mutation (WU-KONG1)" at ClinicalTrials.gov

[FDA_Zegfrovy-1] ^ ^a ^b ^c ^d ^e ^f ^g ^h "FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations". U.S. Food and Drug Administration (FDA). 2 July 2025. Retrieved 7 July 2025. This article incorporates text from this source, which is in the public domain.

[Wang-2] Wang M, Yang JC, Mitchell PL, Fang J, Camidge DR, Nian W, et al. (2022). "Sunvozertinib, a Selective EGFR Inhibitor for Previously Treated Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations". Cancer Discovery. 12 (7): 1676–1689. doi:10.1158/2159-8290.CD-21-1615. PMC 9262839. PMID 35404393.

[3] Wang M, Fan Y, Sun M, Wang Y, Zhao Y, Jin B, et al. (2024). "Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): Single-arm, open-label, multicentre, phase 2 trial". The Lancet Respiratory Medicine. 12 (3): 217–224. doi:10.1016/S2213-2600(23)00379-X. PMID 38101437.{{cite journal}}: CS1 maint: overridden setting (link)

[4] Hidetoshi Hayashi (2024). "Sunvozertinib: the next candidate of TKI for NSCLC". The Lancet Respiratory Medicine. 12 (3): 185–186. doi:10.1016/S2213-2600(23)00419-8. PMID 38101435.

[5] "ASH: With high tumor response, AstraZeneca spinout Dizal explores FDA path and US partner for PTCL drug". Fierce Biotech. 11 December 2023.

[6] Dhillon S (2023). "Sunvozertinib: First Approval". Drugs. 83 (17): 1629–1634. doi:10.1007/s40265-023-01959-5. PMID 37962831.

[7] "FDA Grants Breakthrough Therapy Designation to Sunvozertinib in EGFR Exon20+ NSCLC". targetedonc.com. 9 April 2024.

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