Chemistry:Zenocutuzumab
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 (FDA) of a systemic therapy for people with non-small cell lung cancer or pancreatic adenocarcinoma harboring an neuregulin 1 gene fusion.[2] The FDA considers it to be a first-in-class medication.[5]
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][2]
Adverse effects
The US Food and Drug Administration prescribing information for zenocutuzumab includes a boxed warning for embryo-fetal toxicity.[2]
History
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
Legal status
Zenocutuzumab was approved for medical use in the United States in December 2024.[2][6]
Names
Zenocutuzumab is the international nonproprietary name,[7] and the United States Adopted Name.[8]
References
- ↑ 1.0 1.1 1.2 Cite error: Invalid
<ref>tag; no text was provided for refs namedBizengri FDA label - ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 "FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma". 4 December 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zenocutuzumab-zbco-non-small-cell-lung-cancer-and-pancreatic.
This article incorporates text from this source, which is in the public domain.
- ↑ "Novel Drug Approvals for 2024". 1 October 2024. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024.
- ↑ "Cancer Accelerated Approvals". 1 October 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals.
- ↑ (PDF) New Drug Therapy Approvals 2024 (Report). January 2025. https://www.fda.gov/media/184967/download. Retrieved 21 January 2025.
- ↑ "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.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information 32 (1). 2018.
- ↑ "Zenocutuzumab". https://searchusan.ama-assn.org/finder/usan/search/HI-231/relevant/1/.
External links
- "Zenocutuzumab (Code C152948)". https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI+Thesaurus&code=C152948.
- 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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