Sevabertinib

Last updated

Sevabertinib
Sevabertinib.svg
Clinical data
Trade names Hyrnuo
Other namesBAY2927088, sevabertinib hydrate (JAN JP)
License data
Routes of
administration 		By mouth
Drug class Antineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
Chemical and physical data
Formula C24H25ClN4O5
Molar mass 484.94 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]

Contents

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

Medical uses

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

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

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 priority review, breakthrough therapy, and orphan drug designations. [2]

Society and culture

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

Names

Sevabertinib is the international nonproprietary name. [5]

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

References

  1. 1 2 3 4 5 6 "HYRNUO (sevabertinib) tablets, for oral use" (PDF). Bayer HealthCare Pharmaceuticals Inc. U.S. Food and Drug Administration.
  2. 1 2 3 4 5 6 "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. 1 2 "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

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