Chemistry:Sunvozertinib
Sunvozertinib is an anti-cancer medication used for the treatment of non-small-cell lung cancer.[1][2] It is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.[1][3]
Sunvozertinib was approved for medical use in the United States in July 2025.[4]
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.[4]
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.[4]
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.[4] 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.[4] The primary efficacy population was in 85 participants who received sunvozertinib 200 mg orally once daily with food until disease progression or intolerable toxicity.[4]
The US Food and Drug Administration granted the application for sunvozertinib priority review and breakthrough therapy designations.[4]
References
- ↑ 1.0 1.1 Wang, Mengzhao; Yang, James Chih-Hsin; Mitchell, Paul L.; Fang, Jian; Camidge, D. Ross; Nian, Weiqi; Chiu, Chao-Hua; Zhou, Jianying 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. PMID 35404393.
- ↑ Wang, Mengzhao 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.
- ↑ 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.
- ↑ 4.0 4.1 4.2 4.3 4.4 4.5 4.6 "FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations". 2 July 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20.
This article incorporates text from this source, which is in the public domain.
- ↑ "ASH: With high tumor response, AstraZeneca spinout Dizal explores FDA path and US partner for PTCL drug". Fierce Biotech. 11 December 2023. https://www.fiercebiotech.com/biotech/high-tumor-response-astrazeneca-spinout-dizal-explores-fda-path-and-us-partner-ptcl-drug.
- ↑ Dhillon, Sohita (2023). "Sunvozertinib: First Approval". Drugs 83 (17): 1629–1634. doi:10.1007/s40265-023-01959-5. PMID 37962831. https://figshare.com/articles/online_resource/Sunvozertinib_First_Approval/24293674.
- ↑ "FDA Grants Breakthrough Therapy Designation to Sunvozertinib in EGFR Exon20+ NSCLC". 9 April 2024. https://www.targetedonc.com/view/fda-grants-btd-to-sunvozertinib-in-egfr-exon20-nsclc.
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
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