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.[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]
- ^ a b c "Bizengri- zenocutuzumab injection". DailyMed. 13 December 2024. Retrieved 23 December 2024.
- ^ "Bizengri- zenocutuzumab injection". DailyMed. 18 December 2024. Retrieved 23 December 2024.
- ^ a b c d "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. 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. Archived from the original on 19 April 2024. Retrieved 6 December 2024.
- ^ "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.
- ^ 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.