Sunvozertinib

Last updated

Sunvozertinib
Sunvozertinib structure.svg
Clinical data
Trade names 舒沃哲, Zegfrovy
Routes of
administration 		Oral
ATC code
  • None
Legal status
Legal status
Identifiers
  • 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
PubChem CID
DrugBank
UNII
KEGG
Chemical and physical data
Formula C29H35ClFN7O3
Molar mass 584.09 g·mol−1
3D model (JSmol)
  • 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]

Contents

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

  1. 1 2 3 4 5 6 7 8 "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  2. 1 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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