Sunvozertinib

Sunvozertinib
Clinical data
Trade names	舒沃哲
Routes of; administration	Oral
Legal status
Legal status	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;
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 (trade name 舒沃哲) is a pharmaceutical drug for the treatment of non-small-cell lung cancer (NSCLC).^[1]^[2] It is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.^[1]^[3]

History

Sunvozertinib is being developed by Dizal Pharmaceutical.^[4] 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.^[5] 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.^[6]

References

^ ^a ^b Wang, Mengzhao; Yang, James Chih-Hsin; Mitchell, Paul L.; Fang, Jian; Camidge, D. Ross; Nian, Weiqi; Chiu, Chao-Hua; Zhou, Jianying; Zhao, Yanqiu; Su, Wu-Chou; Yang, Tsung-Ying; Zhu, Viola W.; Millward, Michael; Fan, Yun; Huang, Wen-Tsung; Cheng, Ying; Jiang, Liyan; Brungs, Daniel; Bazhenova, Lyudmila; Lee, Chee Khoon; Gao, Bo; Xu, Yan; Hsu, Wei-Hsun; Zheng, Li; Jänne, Pasi A. (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, 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 Respirator 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. Dec 11, 2023.
^ Dhillon, Sohita (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. April 9, 2024.

[Wang-1] Wang, Mengzhao; Yang, James Chih-Hsin; Mitchell, Paul L.; Fang, Jian; Camidge, D. Ross; Nian, Weiqi; Chiu, Chao-Hua; Zhou, Jianying; Zhao, Yanqiu; Su, Wu-Chou; Yang, Tsung-Ying; Zhu, Viola W.; Millward, Michael; Fan, Yun; Huang, Wen-Tsung; Cheng, Ying; Jiang, Liyan; Brungs, Daniel; Bazhenova, Lyudmila; Lee, Chee Khoon; Gao, Bo; Xu, Yan; Hsu, Wei-Hsun; Zheng, Li; Jänne, Pasi A. (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.

[2] 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.

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

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

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

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

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Clinical data

Trade names	舒沃哲
Routes of administration	Oral
Legal status
Legal status	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
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