Sevabertinib

  1. Home
  2. Wiki

Sevabertinib
Clinical data
Trade namesHyrnuo
Other namesBAY2927088, sevabertinib hydrate (JAN JP)
License data
Routes of
administration		By mouth
Drug classAntineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC24H25ClN4O5
Molar mass484.94 g·mol−1
3D model (JSmol)
  • COC1=C(C=CC=C1Cl)NC2=C(NC3=C2C(=O)NCC3)C4=C(C=NC=C4)OC[C@@H]5COCCO5
  • InChI=InChI=1S/C24H25ClN4O5/c1-31-23-16(25)3-2-4-18(23)29-22-20-17(6-8-27-24(20)30)28-21(22)15-5-7-26-11-19(15)34-13-14-12-32-9-10-33-14/h2-5,7,11,14,28-29H,6,8-10,12-13H2,1H3,(H,27,30)/t14-/m0/s1
  • Key:VYQVHWNNPKOJEA-AWEZNQCLSA-N

Sevabertinib, sold under the brand name Hyrnuo, is an anti-cancer medication used for the treatment of non-small cell lung cancer.[1] Sevabertinib is a kinase inhibitor.[1] It is taken by mouth.[1]

Sevabertinib was approved for medical use in the United States in November 2025.[2]

Medical uses

[edit]

Sevabertinib is indicated for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations.[1][2]

Adverse effects

[edit]

The US prescribing information includes warnings and precautions for diarrhea, hepatotoxicity, interstitial lung disease/pneumonitis, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity.[2]

History

[edit]

Efficacy was evaluated in people with unresectable or metastatic, non-squamous non-small cell lung cancer with HER2 (ERBB2) tyrosine kinase domain activating mutations who had received prior systemic therapy and received sevabertinib in SOHO-01 (NCT05099172), an open-label, single-arm, multi-center, multi-cohort clinical trial.[2] HER2 (ERBB2) activating mutations were determined in tumor tissue or plasma by local laboratories prior to enrollment.[2]

The US Food and Drug Administration granted the application for sevabertinib granted priority review, breakthrough therapy, and orphan drug designations.[2]

Society and culture

[edit]
[edit]

Sevabertinib was approved for medical use in the United States in November 2025.[3][4]

Names

[edit]

Sevabertinib is the international nonproprietary name.[5]

Sevabertinib is sold under the brand name Hyrnuo.[1][3]

References

[edit]
  1. ^ a b c d e f "HYRNUO (sevabertinib) tablets, for oral use" (PDF). Bayer HealthCare Pharmaceuticals Inc. U.S. Food and Drug Administration.
  2. ^ a b c d e f "FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer". U.S. Food and Drug Administration (FDA). 19 November 2025. Retrieved 21 November 2025. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ a b "U.S. FDA Approves Hyrnuo (sevabertinib) for Previously Treated Patients with HER2-Mutated Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer" (Press release). Bayer. 20 November 2025. Retrieved 21 November 2025 – via Business Wire.
  4. ^ "U.S. FDA grants accelerated approval to Bayer's Hyrnuo (sevabertinib) for patients with previously treated advanced HER2-mutant non-small cell lung cancer". Bayer (Press release). 20 November 2025. Retrieved 21 November 2025.
  5. ^ World Health Organization (2025). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 93". WHO Drug Information. 39 (1). hdl:10665/381075.

Further reading

[edit]
  • Le X, Kim TM, Loong HH, Prelaj A, Goh BC, Li L, et al. (November 2025). "Sevabertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer". The New England Journal of Medicine. 393 (18): 1819–1832. doi:10.1056/NEJMoa2511065. PMID 41104928.
  • Siegel F, Siegel S, Kotýnková K, Karsli Uzunbas G, Korr D, Tomono H, et al. (October 2025). "Sevabertinib, a Reversible HER2 Inhibitor with Activity in Lung Cancer". Cancer Discovery. doi:10.1158/2159-8290.CD-25-0605. PMID 41090369.
[edit]
Stub icon

This pharmacology-related article is a stub. You can help Wikipedia by expanding it.