Zenocutuzumab

Last updated

Zenocutuzumab
Monoclonal antibody
Type Whole antibody
Source Humanized
Target HER2, HER3
Clinical data
Trade names Bizengri
Other namesMCLA-128, zenocutuzumab-zbco
License data
Routes of
administration 		Intravenous
Drug class Antineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
Formula C6479H9971N1725O2027S45
Molar mass 145904.79 g·mol−1

Zenocutuzumab, sold under the brand name Bizengri, is a humanized monoclonal antibody used for the treatment of non-small cell lung cancer or pancreatic cancer. [1] It is a low-fucose humanized full-length immunoglobulin G1 bispecific HER2- and HER3-directed antibody. [1]

Contents

The most common adverse reactions include diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain, and edema. [3] The most common grade 3 or 4 laboratory abnormalities include increased gamma-glutamyl transferase, decreased hemoglobin, decreased sodium, and decreased platelets. [3]

Zenocutuzumab was approved for medical use in the United States in December 2024. [3] [4] [5] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with non-small cell lung cancer or pancreatic adenocarcinoma harboring an neuregulin 1 gene fusion. [3] The FDA considers it to be a first-in-class medication. [6]

Medical uses

Zenocutuzumab is indicated for the treatment of adults with advanced, unresectable or metastatic non-small cell lung cancer harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy; adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy. [1] [3]

Adverse effects

The US Food and Drug Administration prescribing information for zenocutuzumab includes a boxed warning for embryo-fetal toxicity. [3]

History

Efficacy was evaluated in the eNRGy study (NCT02912949), a multicenter, open-label, multicohort trial. [3] The trial enrolled 64 adults with advanced or metastatic neuregulin 1 gene fusion-positive non-small cell lung cancer and 30 adults with advanced or metastatic neuregulin 1 gene fusion-positive pancreatic adenocarcinoma who had disease progression following standard of care treatment. [3] Identification of positive neuregulin 1 gene fusion status was prospectively determined by next generation sequencing assays. [3]

The US Food and Drug Administration granted the application for Zenocutuzumab priority review, breakthrough therapy, and orphan drug designations. [3]

Society and culture

Zenocutuzumab was approved for medical use in the United States in December 2024. [3] [7]

Names

Zenocutuzumab is the international nonproprietary name, [8] and the United States Adopted Name. [9]

References

  1. 1 2 3 4 "Bizengri- zenocutuzumab injection". DailyMed. 13 December 2024. Retrieved 23 December 2024.
  2. ↑ "Bizengri- zenocutuzumab injection". DailyMed. 18 December 2024. Retrieved 23 December 2024.
  3. 1 2 3 4 5 6 7 8 9 10 11 "FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma". U.S. Food and Drug Administration (FDA). 4 December 2024. Archived from the original on 4 December 2024. Retrieved 5 December 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  4. ↑ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Archived from the original on 19 April 2024. Retrieved 6 December 2024.
  5. ↑ "Cancer Accelerated Approvals". U.S. Food and Drug Administration (FDA). 1 October 2024. Archived from the original on 27 October 2021. Retrieved 6 December 2024.
  6. ↑ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
  7. ↑ "Merus Announces FDA Approval of Bizengri (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer (NSCLC) Based on Safety and Efficacy Data From the eNRGy Study" (Press release). Merus. 4 December 2024. Retrieved 5 December 2024– via GlobeNewswire.
  8. ↑ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl: 10665/330941 .
  9. ↑ "Zenocutuzumab". American Medical Association. Retrieved 5 December 2024.
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