Zenocutuzumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | HER2, HER3 |
| Clinical data | |
| Trade names | Bizengri |
| Other names | MCLA-128, zenocutuzumab-zbco |
| License data | |
| Routes of administration | Intravenous |
| Drug class | Antineoplastic |
| ATC code |
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| 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]
The most common adverse reactions include diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain, and edema.[2] The most common grade 3 or 4 laboratory abnormalities include increased gamma-glutamyl transferase, decreased hemoglobin, decreased sodium, and decreased platelets.[2]
Zenocutuzumab was approved for medical use in the United States in December 2024.[2][3][4] It is the first approval by the US Food and Drug Administration of a systemic therapy for people with non-small cell lung cancer or pancreatic adenocarcinoma harboring an neuregulin 1 gene fusion.[2]
Medical uses
[edit]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][2]
Adverse effects
[edit]The US Food and Drug Administration prescribing information for zenocutuzumab includes a boxed warning for embryo-fetal toxicity.[2]
History
[edit]Efficacy was evaluated in the eNRGy study (NCT02912949), a multicenter, open-label, multicohort trial.[2] 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.[2] Identification of positive neuregulin 1 gene fusion status was prospectively determined by next generation sequencing assays.[2]
The US Food and Drug Administration granted the application for Zenocutuzumab priority review, breakthrough therapy, and orphan drug designations.[2]
Society and culture
[edit]Legal status
[edit]Zenocutuzumab was approved for medical use in the United States in December 2024.[2][5]
Names
[edit]Zenocutuzumab is the international nonproprietary name,[6] and the United States Adopted Name.[7]
References
[edit]- ^ a b c d "Bizengri (zenocutuzumab-zbco) injection, for intravenous use Initial U.S. Approval: 2024" (PDF). 4 December 2024. Retrieved 5 December 2024.
- ^ a b c d e f g h i j k "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. Retrieved 5 December 2024.
This article incorporates text from this source, which is in the public domain.
- ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 6 December 2024.
- ^ "Cancer Accelerated Approvals". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 6 December 2024.
- ^ "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.
- ^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.
- ^ "Zenocutuzumab". American Medical Association. Retrieved 5 December 2024.
External links
[edit]- "Zenocutuzumab (Code C152948)". NCI Thesaurus.
- Clinical trial number NCT02912949 for "A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)" at ClinicalTrials.gov
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