Danyelza
Intended for US audiences only.

DANYELZA®, Y-mAbs®, Y-mAbs Connect®, and the logos for DANYELZA® and Y-mAbs Connect® are registered trademarks of Y-mAbs Therapeutics, Inc. The logo for Y-mAbs Therapeutics, Inc. is a trademark for Y-mAbs Therapeutics, Inc.

© 2025 Y-mAbs Therapeutics, Inc. All rights reserved. September 2025 NAX-000755

Standing with you in the fight

Navigating high-risk neuroblastoma isn't easy, but you're not alone. Learn how DANYELZA may help support your child's treatment journey.

Other caregivers have been in your shoes before. See how they navigated the HRNB journey

Community

Being a strong advocate for yourself:

Erin shares her personal journey and offers actionable advice for caregivers.

What to expect from DANYELZA

Science

It’s important to know what to potentially expect during DANYELZA treatment

Your child will be given DANYELZA intravenously () by healthcare professionals on days 1, 3, and 5 of a 28-day cycle. Five days before receiving their first infusion of DANYELZA, your child will also start another medicine called granulocyte-macrophage colony-stimulating factor (). GM-CSF can be given at home and helps the body make white blood cells, so the is stronger during treatment.

Starting 5 days before treatment with DANYELZA, your care team may also prescribe a 12-day course of gabapentin to help reduce pain during treatment, which can also be given at home.

DANYELZA treatment schedule showing days 1, 3, and 5 of a 28-day cycle

Each treatment cycle of DANYELZA is 28 days long and your care team will determine if infusions in an setting may be an option. Since every child reacts differently, the number of treatment cycles will depend on your child’s response.

Once your care team notices an initial response to treatment, DANYELZA will be given for at least another five 28-day cycles.

DANYELZA treatment cycles showing response evaluation timeline

A complete response is when the patient shows no physical evidence of disease on examination or imaging tests after treatment. Complete response is sometimes phrased as “no evidence of disease” and abbreviated NED.

A partial response is when a person’s cancer is reduced by at least 50% after treatment.

Side effects and how to manage them

Resources

Helping you understand side effects and how best to manage them

We can help you to gain a better understanding of side effects and how they’re best handled. Based on the clinical studies of DANYELZA®, some side effects can be expected. Your care team will monitor your child closely throughout treatment and will have a plan to help manage any side effects, as needed.

We’ve grouped the side effects below under pain- and nervous system-related side effects. We’ve also listed a few medicines that might help with the pain.

Pain

  • Pain is common with DANYELZA and can be severe. Your child will likely experience pain during the infusion in places such as the belly, bone, neck, legs, or arms. In Study 201, severe pain resolved within an hour in the majority of patients who experienced it

Nervous system problems

  • Severe pain from nerves
    (neuropathic pain)
  • Inflammation of the spinal cord
    Reversible Posterior Leukoencephalopathy Syndrome (RPLS - also known as Posterior Reversibile Encephalopathy Syndrome - PRES), which is a condition of the brain
  • Numbness, tingling, or burning sensation in the arms or legs
  • Nervous system problems of the eye
  • Problems urinating or emptying the bladder (prolonged urinary retention)

The following medicines may help with pain:

  • Preventive pain medicine (eg, gabapentin)
    Taken by mouth for 12 days starting 5 days before the first DANYELZA infusion in each cycle
  • Other pain medicine (eg, opioids)
    Given approximately an hour before the infusion and may be administered by IV as needed for additional pain during the infusion
  • Anesthetic (eg, ketamine)
    Given if the pain is not adequately controlled by opioids. This may make your child sleepy during the infusion

Signs and symptoms of infusion-related reactions during or after DANYELZA treatment include:

  • Swelling of the face, eyes, lips, mouth, or tongue
  • Redness of the face
  • Skin rash or hives
  • Trouble breathing
  • Coughing or wheezing
  • Noisy, high-pitched breathing
  • Feeling faint or dizzy

DANYELZA can also cause fever, nausea, or vomiting during or after the infusion.

Please note: DANYELZA can cause serious infusion-related reactions, which are common with this treatment, and may require immediate medical attention. Signs and symptoms of infusion-related reactions are listed below. Speak with your care team right away if your child experiences any of these side effects while on DANYELZA.

It’s possible to prepare for infusion-related reactions. Your child's care team will offer the following pre-medications:

Steroids (eg, methylprednisolone):
Given by IV between 30 minutes and 2 hours before the first DANYELZA infusion. If your child had a severe reaction before, these medicines may be given at the next infusion or cycle.

Antihistamines (eg, diphenhydramine):
Given 30 minutes before the infusion.

Fever reducers (eg, acetaminophen):
Given 30 minutes before the infusion.

Medicine for nausea/vomiting (eg, antiemetics and H2 antagonists):
Given 30 minutes before the infusion to help reduce nausea and vomiting.

Your child’s care team is more than just doctors and nurses; it also includes a variety of specialists and therapists dedicated to supporting your whole journey.

More help and resources

Resources

Support and Research Groups

We understand that HRNB can sometimes feel like a constant battle for a caregiver. That’s why we’re always here with the help and resources you can count on.

From support groups providing you with information, logistical assistance, and emotional support throughout your child’s neuroblastoma treatment journey to research groups giving you access to helpful resources; you’ll find all the help you need here.

Support Groups:

Arms Wide Open Childhood Cancer Foundation

awoccf.org

The Arms Wide Open Childhood Cancer Foundation is committed to funding pediatric cancer research, supporting families, both financially and emotionally, educating the general public, raising awareness, uniting the childhood cancer community, giving children with cancer a platform to share their voice, and working to ensure children who survive childhood cancer thrive.

Children’s Neuroblastoma Cancer Foundation (CNCF)

cncfhope.org

The premier source for neuroblastoma information and resources, the CNCF is composed of families like yours committed to finding a cure for neuroblastoma through research, education, awareness, and advocacy.

The EVAN Foundation

theevanfoundation.org

While spreading smiles and hope, the Evan foundation drives change in the fight against neuroblastoma.

Isabella Santos Foundation (ISF)

isabellasantosfoundation.org

Established in memory of Isabella Santos, whose desire was to beat cancer, grow her hair, and live her dreams, ISF is dedicated to improving rare pediatric cancer treatment options to increase survival rates of kids with cancer.

Solving Kids’ Cancer

solvingkidscancer.org

Solving Kids’ Cancer focuses on aggressive childhood cancers with low survival rates by helping accelerate new, next-generation treatments.

Research Groups:

Coalition Against Childhood Cancer (CAC2)

cac2.org

CAC2 is a collaborative network of international nonprofits, corporations, where individuals that advance a variety of childhood cancer causes.

Clinicaltrials.gov

Clinicaltrials.gov

A database of privately and publicly funded clinical studies conducted around the world, where individuals can search key terms such as "neuroblastoma".

National Cancer Institute (NCI)

cancer.gov/about-nci

The federal government’s principal agency for cancer research and training.

New Approaches to Neuroblastoma Therapy (NANT)

nant.org

Established in 2000, NANT is the only international clinical trials consortium focused on developing new treatments and biomarkers for relapsed/refractory high-risk neuroblastoma to improve outcome. High-risk neuroblastoma remains a challenge, despite improvements seen with intensive chemotherapy, isotretinoin, and immunotherapy.

Get regular updates by staying connected with us through our social media channels:

Glossary of Important Terms

Resources

Glossary of Important Terms

  • Antibody

    A protein made by white blood cells in response to a foreign substance in the body. This substance, called an antigen, causes an immune response in the body. Each antibody is made to bind to one specific type of antigen and destroy it. Antibodies help the body fight cancer, infection, or other diseases.

  • Anti-drug antibody

    An antibody that binds to a specific drug after repeated administration.

  • Bone marrow

    The soft, sponge-like tissue in the center of most bones. It produces white blood cells, red blood cells, and platelets.

  • Complete response

    When the patient shows no physical evidence of disease on examination or imaging tests after treatment. Complete response is sometimes phrased as "no evidence of disease" and abbreviated NED.

  • Consolidation therapy

    Treatment used to kill any cancer cells that may be left in the body after initial chemotherapy. Consolidation can include treatments like chemotherapy, radiation, stem cell transplant, etc.

  • Curie score

    A numbering system that divides the body into 9 skeletal sections with a tenth soft-tissue section that measures the extent of neuroblastoma still present in the body.

  • Duration of response (DOR)

    The amount of time patients maintain their complete or partial response, without the cancer growing or spreading.

  • Efficacy

    The measurement of how well a medicine works to produce a desired effect.

  • GD2

    A disialoganglioside molecule found on neuroblastoma cells and certain nerve cells.

  • GM-CSF

    Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a medication given with DANYELZA® to help the body's immune system during cancer treatment.

  • High risk

    Neuroblastoma is generally considered high risk when the cancer cannot be surgically removed and it has spread to other parts of the body.

  • Humanized

    A way of describing immunotherapies that are made to more closely resemble antibodies that are naturally present in the human body.

  • Immune system

    A system of cells, tissues, organs, and the substances they make that help the body fight infections and other diseases.

  • Immunotherapy

    A type of medicine that uses substances to stimulate or suppress the immune system to help the body fight the disease.

  • Incomplete responses

    This may refer to: stable disease, when the cancer stays the same; partial response, when the cancer is reduced by at least 50% after treatment; and minor response, when the cancer is reduced in some places but not all.

  • Induction therapy

    An initial attempt to treat the cancer that often includes chemotherapy and surgery.

  • Infusion

    A way to put fluids, including drugs, into the bloodstream. It is often called an intravenous infusion, which means an infusion into a vein.

  • IV (intravenous)

    IV usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein.

  • Maintenance therapy

    Attempts to treat the cancer throughout the body with medications after initial treatment. These medications may include chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.

  • MIBG

    A meta-iodobenzylguanidine (MIBG) scan is a procedure that helps detect the presence of neuroblastoma and its location in the body.

  • Outpatient

    A term that refers to medical care that can be completed without a patient staying in a hospital overnight.

  • Overall response rate (ORR)

    The percentage of patients in a study who have either a complete or partial response to treatment.

  • Partial response (PR)

    This is when a person's cancer is reduced by at least 50% after treatment.

  • Refractory

    A term used to describe cancer that does not respond completely to treatment.

  • Relapsed

    A term used to describe cancer that has returned following a period of improvement as a result of treatment.

  • Remission

    A decrease or disappearance of cancer signs and symptoms.

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