WHAT IS BLINCYTO® (blinatumomab)?
BLINCYTO® is a prescription medicine used to treat adults and children 1 month and older with:

B-cell precursor acute lymphoblastic leukemia (ALL) in remission when only a small number of cancer cells remain in the body (minimal residua …read more

BLINCYTO® is a prescription medicine used to treat adults and children 1 month and older with:

B-cell precursor acute lymphoblastic leukemia (ALL) in remission when only a small number of cancer …read more

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Important Safety Information Prescribing Information Medication Guide Indications Health Care Professionals Contact Us

What is BLINCYTO®? BLINCYTO® gives you a better chance against B-cell precursor acute lymphoblastic leukemia (BCP-ALL)1

Not actual patients.

What is ALL?

ALL is a cancer of the blood and bone marrow

Your bone marrow is responsible for making white blood cells, which are important to your immune system. That’s because they play a role in helping your body fight infection and disease.2,3

However, when you have ALLA type of cancer of the blood and bone marrow that affects white blood cells., your bone marrow makes too many white blood cells, and they do not work properly.2,3

After being treated for ALLA type of cancer of the blood and bone marrow that affects white blood cells., you may achieve remissionA response to treatment where signs and symptoms of cancer have decreased or disappeared. This does not mean that the cancer has been cured.. This means that your body is free of signs and symptoms of leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream.. But it does not always mean that the leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. is completely gone. Even if you are feeling better, your doctor may still test to see if leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. is there and may give you more medicine to help keep the leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. from coming back.2,4

  • What does it mean to have ALL?

    ALLA type of cancer of the blood and bone marrow that affects white blood cells. is a type of sickness, called leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream., in the blood. There are different types of cells in the blood. Some are healthy, but other cells can become sick and are called leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. cells. The number of leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. cells can grow and cause problems for the healthy cells.2,3

    cartoon showing small cells and particles representing immune system activity against cancer cells

    After treatment, remissionA response to treatment where signs and symptoms of cancer have decreased or disappeared. This does not mean that the cancer has been cured. means that the signs and symptoms of your leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. have decreased or disappeared, and you may be feeling better.2

    Even if you’re feeling better after initial chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”., your doctor may still do tests to see if the leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. is gone. More medicine may be needed to help keep you feeling well and prevent the leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. from coming back.2,4-6

    cartoon showing small cells and particles representing immune system activity against cancer cells
Why testing for minimal residual disease (MRD) is important

What makes BLINCYTO® different?

BLINCYTO® uses your body’s own immune system to fight leukemia1

BLINCYTO® is an immunotherapyA type of medicine that uses your body’s own immune system to help fight conditions such as cancer. used to treat BCP-ALLA fast-growing type of leukemia (blood cancer) in which too many immature white blood cells are found in the bone marrow and blood. in adults and children one month or older.1

It is different from chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”. because it engages your immune system to find and kill leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. cells.1,2

How BLINCYTO® works7

diagram of BLINCYTO® connecting immune and leukemia cells to help the immune cell kill the cancer cell
diagram of BLINCYTO® connecting immune and leukemia cells to help the immune cell kill the cancer cell

FINDS

LeukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. cells can hide from healthy immune cells. BLINCYTO® helps healthy immune cells find leukemia cells and bring them together.1,7

ACTIVATES

When the healthy cells and leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. cells are connected, BLINCYTO® activates the healthy immune cells to release specialized proteins called granzymes.7

KILLS

The granzymes then attack and kill the leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. cells.7

*CD3 and CD19 are targets that help BLINCYTO® find and identify healthy immune cells and leukemia cells.1,7

  • How BLINCYTO® works in the body

    BLINCYTO® is a medicine that your doctor may use to treat your leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream.. It is different from chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”.. It works with the cells in your body. BLINCYTO® helps the healthy cells find and get rid of the leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. cells.1,2

    cartoon showing how BLINCYTO® helps a healthy cell find and connect to a cancer cell

How BLINCYTO® works: for pediatric patients

Ask your doctor if adding BLINCYTO® to your treatment plan after initial treatment (at consolidation) is right for you.

Why your MRD status matters

Even when you are in remissionA response to treatment where signs and symptoms of cancer have decreased or disappeared. This does not mean that the cancer has been cured., small amounts of disease may remain. That’s why your doctor may test you for minimal residual disease"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques., or MRD"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques..2

MRD-positive diagram showing remaining cancer cells among healthy cells

MRD-positive

Even after achieving remissionA response to treatment where signs and symptoms of cancer have decreased or disappeared. This does not mean that the cancer has been cured. with chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”., there could still be some underlying disease. This is known as MRD"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques.-positive.2,4

It is good to know your MRD"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques. status, because MRD"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques. can increase the risk of a relapseThe return of a disease or the signs and symptoms of a disease after a period of improvement.—which is when the signs and symptoms of your leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. return after a period of improvement.2,4

MRD-negative diagram showing no detectable cancer cells among healthy cells

MRD-negative

Your MRD"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques. test may also show that you are MRD"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques.-negative. This means no cancer cells can be detected, which is a good thing, but there could still be some underlying disease.2

However, there is a risk of relapseThe return of a disease or the signs and symptoms of a disease after a period of improvement. even if you are MRD"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques.-negative, so knowing your status is still important.2,4

  • Why you should know about MRD

    Even though you may feel better, your doctor may still test you to see if you have a small amount of cancer left. This small amount of cancer is called MRD"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques., which can increase the risk of relapseThe return of a disease or the signs and symptoms of a disease after a period of improvement.. RelapseThe return of a disease or the signs and symptoms of a disease after a period of improvement. means your cancer has come back.1,2,4,6

Why BLINCYTO®?

The good news is that BLINCYTO® has been proven to help people with different types of ALLA type of cancer of the blood and bone marrow that affects white blood cells. live longer—whether you are MRD"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques.-positive or MRD"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques.-negative.1

Read on to see how BLINCYTO® can help:8

  • People with Philadelphia chromosomeAn abnormal fusion of 2 genes that can cause immature white blood cells to grow uncontrollably and build up in the bone marrow and blood. If the Philadelphia chromosome is present, then the cancer is known as Ph(+). If it is not present, it is known as Ph(–).–negative [Ph(–)] BCP-ALLA fast-growing type of leukemia (blood cancer) in which too many immature white blood cells are found in the bone marrow and blood. who’ve had initial therapy and are now in the next phase of treatment (consolidationA phase of treatment given after cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body.)
  • People whose BCP-ALLA fast-growing type of leukemia (blood cancer) in which too many immature white blood cells are found in the bone marrow and blood. is in remissionA response to treatment where signs and symptoms of cancer have decreased or disappeared. This does not mean that the cancer has been cured., but still have detectable traces of cancer (MRD"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques.) after chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”.
  • People with BCP-ALLA fast-growing type of leukemia (blood cancer) in which too many immature white blood cells are found in the bone marrow and blood. whose cancer has returned (relapsed) or did not respond to treatment (refractoryWhen a disease does not respond to treatment.)
Summary
+—

Learn about acute lymphoblastic leukemia
(ALL), remission, minimal residual disease (MRD) status, and how BLINCYTO® (blinatumomab) treatment works differently than chemotherapy. A special section is provided to help you talk to kids.

JUMP TO

Important Safety
Information

What is the most important information I should know about BLINCYTO®?

  • Call your health care provider or get emergency medical help right away if you get any of the symptoms listed below:
    • BLINCYTO® may cause serious side effects that can be severe, life-threatening, or lead to death, including:
      • Cytokine Release Syndrome (CRS) and infusion reactions. Symptoms of CRS and infusion reactions may include: fever, tiredness or weakness, dizziness, headache, low blood pressure, nausea, vomiting, chills, face swelling, wheezing or trouble breathing, and skin rash.
      • Neurologic problems. Symptoms of neurologic problems may include: seizures, difficulty in speaking or slurred speech, loss of consciousness, trouble sleeping, confusion and disorientation, loss of balance, headache, difficulty with facial movements, hearing, vision, or swallowing, and tremors. People with Down Syndrome may have a higher risk of seizures with BLINCYTO® treatment and may be given anti‑seizure medicine before starting BLINCYTO® treatment.
    • Your health care provider will check for these problems during treatment with BLINCYTO®. Your health care provider may temporarily or completely stop your treatment with BLINCYTO® if you have severe side effects.

Who should not receive BLINCYTO®?

  • Do not receive BLINCYTO® if you are allergic to blinatumomab or to any of the ingredients of BLINCYTO®.

Before receiving BLINCYTO®, tell your health care provider about all of your medical conditions, including if you or your child:

  • have a history of neurological problems, such as seizures, confusion, trouble speaking or loss of balance
  • have Down Syndrome
  • have an infection
  • have ever had an infusion reaction after receiving BLINCYTO® or other medications
  • have a history of radiation treatment to the brain, or chemotherapy treatment
  • are scheduled to receive a vaccine. You should not receive a “live vaccine” within 2 weeks before you start treatment with BLINCYTO®, during treatment, and until your immune system recovers after you receive your last cycle of BLINCYTO®. If you are not sure about the type of vaccine, ask your health care provider.
  • are pregnant or plan to become pregnant. BLINCYTO® may harm your unborn baby. Tell your health care provider if you become pregnant during treatment with BLINCYTO®.
    • If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with BLINCYTO®.
    • Females who are able to become pregnant should use an effective form of birth control (contraception) during treatment with BLINCYTO®, and for 48 hours after your last dose of BLINCYTO®.
  • are breastfeeding or plan to breastfeed. It is not known if BLINCYTO® passes into your breast milk. You should not breastfeed during treatment with BLINCYTO® and for 48 hours after your last dose.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving BLINCYTO®?

  • Do not drive, operate heavy machinery, or do other dangerous activities while you are receiving BLINCYTO® because BLINCYTO® can cause neurological symptoms such as dizziness, seizures, and confusion.

BLINCYTO® may cause serious side effects, including:

  • Infections. BLINCYTO® may cause life-threatening infections that may lead to death. Tell your health care provider right away in case you develop any
    signs or symptoms of an infection.
  • Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can be life-threatening and may lead to death. Tell your
    healthcare provider right away if you have any symptoms of TLS during treatment with BLINCYTO®, including: nausea and vomiting, confusion,
    shortness of breath, irregular heartbeat, dark or cloudy urine, reduced amount of urine, unusual tiredness, muscle cramps.
  • Low white blood cell counts (neutropenia). Neutropenia is common with BLINCYTO® treatment and may sometimes be life-threatening. Low white blood cell counts can increase your risk of infection. Your health care provider will do blood tests to check your white blood cell counts during
    treatment with BLINCYTO®. Tell your health care provider right away if you get a fever.
  • Abnormal liver blood test. Your health care provider will do blood tests to check your liver before you start BLINCYTO® and during treatment with BLINCYTO®.
  • Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in patients treated with BLINCYTO® and corticosteroids. It may be severe and
    lead to death. Tell your health care provider right away if you have severe stomach-area pain that does not go away. The pain may happen with or without nausea and vomiting.
  • Your health care provider will do blood tests during treatment to check for side effects.

The most common side effects

  • The most common side effects of BLINCYTO® include:
    • Fever
    • Reactions related to infusion of the medicine such as face swelling, low blood pressure, and high blood pressure (infusion-related reactions)
    • Headache
    • Infection
    • Muscle, joint, and bone pain
    • Low white blood cell count (neutropenia)
    • Nausea
    • Low red blood cell count (anemia)
    • Low platelet count (thrombocytopenia)
    • Diarrhea

These are not all the possible side effects of BLINCYTO®.

Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read the accompanying Medication Guide before you or your child receives BLINCYTO® and before each BLINCYTO® infusion and discuss it with your doctor.

Please see BLINCYTO® full Prescribing Information, including BOXED WARNINGS and Medication Guide.

Important Safety Information

What is the most important information I should know about BLINCYTO®?

  • Call your health care provider or get emergency medical help right away if you get any of the symptoms listed below:
    • BLINCYTO® may cause serious side effects that can be severe, life-threatening, or lead to death, including:
      • Cytokine Release Syndrome (CRS) and infusion reactions. Symptoms of CRS and infusion reactions may include: fever, tiredness or weakness, dizziness, headache, low blood pressure, nausea, vomiting, chills, face swelling, wheezing or trouble breathing, and skin rash.
Reference: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Litzow MR, Sun Z, Mattison RJ, et al. Blinatumomab for MRD-negative acute lymphoblastic leukemia in adults. N Engl J Med. 2024;391:320-333. 3. Gupta S, Rau RE, Kairalla JA, et al. Blinatumomab in standard-risk B-cell acute lymphoblastic leukemia in children. N Engl J Med. 2025;392:875-891.
References: 1. BLINCYTO® (blinatumomab) medication guide, Amgen. 2. National Cancer Institute. Common terminology criteria for adverse events (CTCAE) version 4.0. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v4_Quick_Reference_8.5x11.pdf. Accessed April 4, 2026. 3. Shimabukuro-Vornhagen A, Gödel P, Subklewe M, et al. Cytokine release syndrome. J Immunother Cancer. 2018;6:56. 4. BLINCYTO® (blinatumomab) prescribing information, Amgen. 5. Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Bio Blood Marrow Transport. 2019;25:625-638.
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. National Cancer Institute. NCI dictionary of cancer terms. https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed April 17, 2026. 3. BLINCYTO® (blinatumomab) medication guide, Amgen.
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. BLINCYTO® (blinatumomab) medication guide, Amgen.
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Nagorsen D, Baeuerle PA. Immunomodulatory therapy of cancer with T cell-engaging BiTE antibody blinatumomab. Exp Cell Res. 2011;317:1255-1260. 3. BLINCYTO® (blinatumomab) medication guide, Amgen. 4. National Cancer Institute. NCI dictionary of cancer terms. https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed April 17, 2026. 5. Brüggemann M, Gökbuget N, Kneba M. Acute lymphoblastic leukemia: monitoring minimal residual disease as a therapeutic principle. Semin Oncol. 2012;39:47-57.
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. National Cancer Institute. NCI dictionary of cancer terms. https://www.cancer.gov/publications/
dictionaries/cancer-terms. Accessed April 17, 2026. 3. Children’s Hospital of Philadelphia. Acute Lymphoblastic Leukemia (ALL). https://www.chop.edu/conditionsdiseases/acute-
lymphoblastic-leukemia-all. Accessed April 17, 2026. 4. Brüggemann M, Gökbuget N, Kneba M. Acute lymphoblastic leukemia: monitoring minimal residual disease as a therapeutic principle. Semin Oncol. 2012;39:47-57. 5. Litzow MR, Sun Z, Mattison RJ, et al. Blinatumomab for MRD-negative acute lymphoblastic leukemia in adults. N Engl J Med.
2024;391:320-333. 6. Gupta S, Rau RE, Kairalla JA, et al. Blinatumomab in standard-risk B-cell acute lymphoblastic leukemia in children. N Engl J Med. 2025;392:875-891. 7. Nagorsen D, Baeuerle PA. Immunomodulatory therapy of cancer with T cell-engaging BiTE antibody blinatumomab. Exp Cell Res. 2011;317:1255-1260. 8. BLINCYTO® (blinatumomab) medication guide, Amgen.
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Litzow MR, Sun Z, Mattison RJ, et al. Blinatumomab for MRD-negative acute lymphoblastic leukemia in adults. N Engl J Med. 2024;391:320-333. 3. Data on file, Amgen; 2024. 4. BLINCYTO® (blinatumomab) medication guide, Amgen. 5. Brüggemann M, Gökbuget N, Kneba M. Acute lymphoblastic leukemia: monitoring minimal residual disease as a therapeutic principle. Semin Oncol. 2012;39:47-57. 6. National Cancer Institute. NCI dictionary of cancer terms. https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed April 17, 2026. 7. Dombret H, Topp MS, Schuh A, et al. Blinatumomab versus chemotherapy in first salvage or in later salvage for B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2019;60:2214-2222.
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