Bizengri

Pronunciation: Bi-zen-gree
Generic name: zenocutuzumab
Dosage form: injection for intravenous use

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 12, 2024.

What is Bizengri?

Bizengri is used to treat certain types of lung cancer or pancreatic cancer in adults. Bizengri (zenocutuzumab-zbco) is a biologic.

Bizengri’s mechanism of action involves binding to HER2 (Human epidermal growth factor receptor-2) and HER3 which are proteins that play a key role in the growth of certain cancers. Bizengri utilizes the Merus Dock & Block mechanism to first dock onto HER2, then block HER3’s ability to bind NRG1 (Neuregulin 1 – a protein-coding gene). Bizengri belongs to the drug class called bispecific HER2- and HER3-directed antibodies.

Bizengri first gained FDA approval on December 4, 2024, under the accelerated approval designation, which is contingent upon continued benefits (overall response rate and duration of response) being shown in clinical trials.

Bizengri uses

Bizengri is used to treat adults with:

• non-small cell lung cancer (NSCLC):
  • that has a neuregulin 1 (NRG1) gene fusion and cannot be removed by surgery or has spread to other parts of the body (advanced unresectable or metastatic), and
  • whose disease has worsened on or after prior cancer treatment.
• pancreatic cancer called pancreatic adenocarcinoma:
  • that has a neuregulin 1 (NRG1) gene fusion and cannot be removed by surgery or has spread to other parts of the body (advanced unresectable or metastatic), and
  • whose disease has worsened on or after prior cancer treatment.

It is not known if Bizengri is safe and effective in children.

Is Bizengri chemotherapy?

Bizengri is not chemotherapy, it is a targeted treatment.

Bizengri side effects

The most common side effects of Bizengri include:

• diarrhea
• rash
• muscle or bone pain
• constipation
• tiredness
• vomiting
• nausea
• stomach-area (abdominal) pain
• shortness of breath
• swelling of your breasts, face, ankles, or legs.

The most common severe abnormal blood test results with Bizengri include:

• increased blood levels of liver enzymes
• decreased blood level of sodium, bilirubin, magnesium, and phosphate
• decreased red blood cell counts
• an increase in the time that it takes your blood platelet counts to clot.

Serious side effects and warnings

Bizengri carries a Boxed Warning for harm to an unborn baby.

Harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with Bizengri. Females who can become pregnant:

• Your healthcare provider will do a pregnancy test before you start treatment with Bizengri.
• Use effective birth control (contraception) during treatment and for 2 months after your last dose of Bizengri.

Other serious side effects of Bizengri include the following.

Infusion-related, allergic, and anaphylactic reactions. Bizengri may 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
• itching or rash
• nausea, vomiting, or diarrhea
• shortness of breath or wheezing
• fever
• chest discomfort
• cough
• feeling light-headed
• sudden swelling of your face, tongue,
• dizziness
• throat, or troubled swallowing
• back or neck pain
• throat tightness or discomfort
• feeling of numbness or tingling

Lung problems. Bizengri may 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
• cough
• shortness of breath
• fever.

Heart problems that may affect your heart’s ability to pump blood. Bizengri may 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. Tell your healthcare provider right away if you develop any new or worsening symptoms of heart problems, including:

• shortness of breath
• irregular heartbeat
• coughing
• sudden weight gain
• tiredness
• dizziness or feeling light-headed
• swelling of your feet, ankles, or legs
• loss of consciousness.

Your healthcare provider will check you for these side effects during your treatment with Bizengri and may delay your treatment, slow the infusion rate, or completely stop your treatment with Bizengri if you develop severe side effects.

These are not all of the possible side effects of Bizengri. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before receiving

Before receiving Bizengri, tell your healthcare provider about all your medical conditions, including if you:

• have lung or breathing problems other than your lung cancer
• have or have had any heart problems
• are pregnant or intend to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Bizengri can seriously harm an unborn baby and you should not be pregnant when starting treatment. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with Bizengri. Females who can become pregnant:

• Your healthcare provider will do a pregnancy test before you start treatment with Bizengri
• Use effective birth control (contraception) during treatment and for 2 months after your last dose of Bizengri.

Breastfeeding

It is not known if Bizengri passes into your breast milk. Do not breastfeed during treatment and for 2 months after your last dose of Bizengri.

How will I receive Bizengri?

Bizengri will be given to you by your healthcare provider as an intravenous (IV) infusion into your vein, usually over 4 hours.

• Bizengri is usually given 1 time every 2 weeks.

Your healthcare provider will decide how many treatments you will need.

Bizengri dosage

The recommended dosage of Bizengri is 750 mg every 2 weeks until disease progression or unacceptable toxicity.

The following premedications are recommended to be given before each Bizengri infusion to reduce the risk of infusion-related reactions:

• Dexamethasone 10 mg either orally or intravenously (for the first infusion and then optional)
• Acetaminophen 1000 mg either orally or intravenously
• Dexchlorpheniramine 5 mg either orally or intravenously (or another anti-H1 equivalent).

What other drugs will affect Bizengri?

Tell your healthcare provider about all your medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Bizengri ingredients

Active ingredient: zenocutuzumab-zbco

Inactive ingredients: histidine, L-histidine hydrochloride monohydrate, polysorbate 20, trehalose, and water for injection

Who makes Bizengri?

Merus N.V. makes Bizengri.

Bizengri Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Bizengri.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer