Bizengri FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 5, 2024.
FDA Approved: Yes (First approved December 4, 2024)
Brand name: Bizengri
Generic name: zenocutuzumab-zbco
Dosage form: Injection
Company: Merus N.V.
Treatment for: Non Small Cell Lung Cancer, Pancreatic Cancer
Bizengri (zenocutuzumab-zbco) is a bispecific HER2- and HER3-directed antibody for the treatment of patients with neuregulin 1 fusion positive (NRG1+) non-small cell lung cancer (NSCLC) and NRG1+ pancreatic adenocarcinoma.
- Bizengri is indicated for the treatment of:
- adults with advanced, unresectable or metastatic NSCLC harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.*
- adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.*
*This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). - NRG1 gene fusions are oncogenic drivers that have been detected in NSCLC, pancreatic adenocarcinoma, and other solid tumors. NRG1 fusions are rare, occurring in less than 1% of solid tumors. The NRG1 gene encodes neuregulin, the ligand for HER3.
- Bizengri is a Biclonics® bispecific antibody that utilizes the Merus Dock & Block® mechanism to bind to the extracellular domains of HER2 and HER3 expressed on the surface of cells, including tumor cells, inhibiting HER2:HER3 dimerization and preventing NRG1 binding to HER3.
It works in the treatment of NRG1+ cancers by inhibiting oncogenic signaling pathways, leading to inhibition of tumor cell proliferation and blocking tumor cell survival. - FDA accelerated approval of Bizengri was based on data from the eNRGy trial.
- In patients with NRG1+ pancreatic adenocarcinoma (n=30), Bizengri demonstrated an overall response rate (ORR) of 40% (95% CI, 23%-59%) with duration of response (DOR) ranging from 3.7 months to 16.6 months.
- In patients with NRG1+ NSCLC (n=64), Bizengri demonstrated an ORR of 33% (95% CI, 22%-46%) and a median DOR of 7.4 months (95% CI, 4.0-16.6). - Bizengri is administered by intravenous infusion over 4 hours, every 2 weeks until disease progression or unacceptable toxicity. Premedications should be administered before each infusion to reduce the risk of infusion-related reactions.
- The Bizengri product label carries a Boxed Warning for embryo-fetal toxicity. Warnings and precautions associated with Bizengri include infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis, and left ventricular dysfunction.
- Common adverse reactions (≥ 10%) include diarrhea musculoskeletal pain, fatigue, nausea, infusion-related reactions (IRR), dyspnea, rash, constipation, vomiting, abdominal pain, and edema.
Common Grade 3 or 4 laboratory abnormalities (≥ 2%) include increased GGT, decreased hemoglobin, decreased sodium, decreased platelets, increased AST, increased ALT, increased alkaline phosphatase, decreased magnesium, decreased phosphate, increased aPTT and increased bilirubin.
Development timeline for Bizengri
Further information
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