Prescription medicine
Zenocutuzumab Brand names: Bizengri
Zenocutuzumab (Bizengri) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the zenocutuzumab FDA label on DailyMed (effective May 19, 2026); every zenocutuzumab label on DailyMed.
Highlights of the record
FDA label of May 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
EMBRYO-FETAL TOXICITY.
Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception [see Warnings and Precautions (5.4), Use in Specific Populations (8.1 , 8.3) ]. WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception [see Warnings and Precautions (5.4), Use in Specific Populations (8.1 , 8.3) ].
Used for
From the label: indications and usageBIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with dis
Forms and strengths
- 20 mg/ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8 through July 30, 2026
What is zenocutuzumab used for?
From the label: indications and usageBIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 ) Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. […]
Conditions named in the indications of zenocutuzumab's FDA labels, with every medicine labeled for each:
From other zenocutuzumab labelsLung cancer: Unresectable or Metastatic NRG1 Fusion-Positive Non-Small Cell Lung Cancer BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene …
Source: FDA drug label (BIZENGRI), Partner Therapeutics, Inc., effective May 19, 2026 (SPL set 203daea4-fc87-40a4-a92f-ba2351b16de1), via openFDA; the full label on DailyMed
What does the patient leaflet for zenocutuzumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about BIZENGRI?BIZENGRI can cause serious side effects, including: Infusion-related, allergic and anaphylactic reactions. BIZENGRI can cause serious infusion-related and allergic reactions that can be life-threatening. Infusion-related reactions are also common during BIZENGRI treatment. Before each BIZENGRI infusion, your healthcare provider will give you medicines to help reduce your chance of getting infusion-related reactions. Your healthcare provider will monitor you for signs and symptoms during your infusion and for at least 1 hour after your first infusion and as needed. Tell your healthcare provider right away if you develop any of the following signs or symptoms during or after your BIZENGRI infusion: chills or shaking nausea, vomiting, or diarrhea fever cough sudden swelling of your face, tongue, throat, or troubled swallowing throat tightness or discomfort itching or rash shortness of breath or wheezing chest discomfort feeling light-headed dizziness back or neck pain feeling of numbness or tingling Lung problems. BIZENGRI can cause serious lung problems that may be life-threatening. If you develop lung problems, your healthcare provider may treat you with corticosteroid medicines. Tell your healthcare provider right away if you develop any new or worsening symptoms of lung problems, including: trouble breathing shortness of breath cough fever Heart problems that may affect your heart's ability to pump blood. BIZENGRI can cause serious and life-threatening heart problems that may lead to death. Your healthcare provider will check your heart function before you start treatment with BIZENGRI and as needed during your treatment. […]
Source: FDA drug label (BIZENGRI), Partner Therapeutics, Inc., effective May 19, 2026 (SPL set 203daea4-fc87-40a4-a92f-ba2351b16de1), via openFDA; the full label on DailyMed
Is there a generic for zenocutuzumab (Bizengri)?
No generic zenocutuzumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the zenocutuzumab label say about other medicines?
The zenocutuzumab label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Prior to the first BIZENGRI infusion, premedicate with a corticosteroid, an H1 antihistamine and acetaminophen to reduce the risk of IRRs [see Dosage and Administration (2.4) ]. |
Source: FDA drug label (BIZENGRI), Partner Therapeutics, Inc., effective May 19, 2026 (SPL set 203daea4-fc87-40a4-a92f-ba2351b16de1), via openFDA; the full label on DailyMed
What do FAERS reports show for zenocutuzumab?
The FDA Adverse Event Reporting System holds 8 reports that list zenocutuzumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 1 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as zenocutuzumab?
16 other medicines are given the same way (intravenous) and in the same FDA class as zenocutuzumab or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Pemetrexed | Lung cancer | 15 labelers | n/a | A presentation being discontinued |
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Topotecan | Lung cancer | 4 labelers | n/a | No current entry |
| Nivolumab | Lung cancer | none listed | n/a | No current entry |
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
| Durvalumab | Lung cancer | none listed | n/a | No current entry |
| Ipilimumab | Lung cancer | none listed | n/a | No current entry |
| Ramucirumab | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as zenocutuzumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to zenocutuzumab
- 16 medicines for the same use
- Zenocutuzumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other