DANYELZA is a prescription medicine used in combination with a medicine called granulocyte-macrophage colony-stimulating factor (GM-CSF) to treat children 1-year of age and older and adults with high-risk neuroblastoma in the bone or bone marrow that:
- has come back (relapsed) or that did not respond to previous treatment (refractory), and
- has shown a partial response, minor response, or stable disease to prior therapy.
DANYELZA is approved based on two clinical studies that looked at reducing tumor size. DANYELZA is still being studied to confirm the study results and the clinical benefit of treatment.
See more >The established name for DANYELZA is naxitamab-gqgk. You may also hear it referred to as Hu3F8 because that is what it was called when it was being studied in one of the clinical trials.
DANYELZA is the ONLY FDA-approved immunotherapy for high-risk neuroblastoma that:
- Is specifically for RELAPSED or REFRACTORY disease in the bone or bone marrow after a partial response, minor response, or stable disease
- Is HUMANIZED, or made to more closely resemble antibodies found in the human body
- Has the option to be administered in an OUTPATIENT setting, based on what your child’s doctor decides
DANYELZA is used in combination with another medicine called granulocyte-macrophage colony-stimulating factor (GM-CSF).
Learn more >DANYELZA is given intravenously (IV) by a team of healthcare professionals who will monitor your child closely throughout the infusion. It is also given with another medicine called granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF can be given at home and starts 5 days before the first DANYELZA infusion.
See full dosing and administration information >On Day 1 of Cycle 1, the DANYELZA infusion will be 60 minutes, as tolerated. The rest of the DANYELZA infusions will be 30-60 minutes, as tolerated.
DANYELZA was studied in an outpatient setting, which may give your child the option of doing inpatient or outpatient treatment. Your child’s doctor will decide which is most appropriate for your child.
Since every child is different, it’s difficult to know exactly how many treatment cycles your child may need. Once your child’s doctor sees an initial response to treatment, DANYELZA will be given for another 5 cycles every 4 weeks. From there, your doctor may repeat treatment cycles every 8 weeks.
Your child’s doctor will continue monitoring your child’s response to determine if treatment should continue. They will stop treatment if your child’s disease progresses or if they cannot tolerate the side effects.
DANYELZA can cause serious infusion-related reactions that require immediate medical attention. Infusion-related reactions are common with DANYELZA.
Signs and symptoms of infusion-related reactions during or after DANYELZA treatment include:
- Swelling of the face, eyes, lips, mouth, or tongue
- Itching
- 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 nervous system problems such as severe pain from nerves (neuropathic pain), including pain in the belly (abdomen), bone, neck, legs, or arms. Pain is common with DANYELZA and can be severe.
Other nervous system problems include:
- Inflammation of the spinal cord
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS – also known as Posterior Reversible 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 your bladder (prolonged urinary retention)
Your child will be closely monitored by their care team for side effects throughout treatment. This will happen whether they receive DANYELZA in an inpatient or an outpatient setting.
There are recommendations that your child’s care team will follow to help manage side effects. Your child’s care team will give your child certain medicines before and during DANYELZA infusions to help manage pain and infusion-related reactions.
See full list of medications to help manage side effects >It is possible to get DANYELZA without traveling to another treatment center; however, if you are unable to access DANYELZA at your home hospital, you can use our treatment center locator to find a hospital or center that already offers it.
Learn more >See list of third-party community groups who can help provide you with logistical assistance.
Note: Third-party organizations are not associated with Y-mAbs Therapeutics, Inc.; specific details and eligibility requirements may vary by organization.
See groups >Many do, but every insurance plan is different. Speak with a Y-mAbs Connect case manager to help confirm your eligibility by calling 1-833-33YMABS (1-833-339-6227), option 2, Monday through Friday (8 AM to 8 PM ET).
Get more info >DANYELZA Caregiver Connection is a program designed to help caregivers of children with relapsed or refractory high-risk neuroblastoma. We aim to connect you with resources and information about treatment with DANYELZA from the perspective of someone who has been there before.
Through this program, you can engage with stories of caregivers who have been through DANYELZA treatment with their child. You can access these stories by watching videos, reading tips, attending live events, or joining the discussion on our Facebook page.
Connect now >Yes! By joining our email list, you can stay up-to-date on news and events related to DANYELZA Caregiver Connection. You will also receive information about DANYELZA treatment.
Sign up now >Important terms for understanding DANYELZA
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Antibody
An antibody is 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. Antibody therapies use antibodies to help the body fight cancer, infection, or other diseases.
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Bone marrow
Bone marrow is the soft, sponge-like tissue in the center of most bones. It produces white blood cells, red blood cells, and platelet.
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Complete response
A complete response, or CR, is when the patient showed 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.
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Consolidation
Consolidation therapy is 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.
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GD2
GD2 is a molecule found on neuroblastoma cells and certain nerve cells.
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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.
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Humanized
Humanized is a way of describing immunotherapies that are made to more closely resemble antibodies that are naturally present in the human body.
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Immune system
The immune system is made up of all the cells, tissues, organs, and the substances they make that help the body fight infections and other diseases.
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Immunotherapy
Immunotherapy is a type of medicine that uses substances to stimulate or suppress the immune system to help the body fight the disease.
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Induction
Induction therapy is an initial attempt to treat the cancer and often includes chemotherapy and surgery.
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Infusion
An infusion is a way to put fluids, including drugs, into the bloodstream. It is often called an intravenous infusion, which means an infusion into a vein.
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IV (intravenous)
IV is short for intravenous and usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein.
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Maintenance
Maintenance therapy is the attempt to treat the cancer throughout the body with medications after initial treatment. These medications may include chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.
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Outpatient
Outpatient refers to medical care that can be completed without a patient staying in a hospital overnight.
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Overall response rate (ORR)
Overall response rate is the percentage of patients in a study who have either a complete or partial response to treatment.
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Partial response (PR)
A partial response is when a patient’s cancer is reduced by at least 50% after treatment.
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Refractory
Refractory is a term used to describe cancer that does not respond completely to initial treatment.
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Relapsed
Relapsed is a term used to describe cancer that has returned following a complete response to previous treatment.
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Remission
Remission is a decrease or disappearance of cancer signs and symptoms.
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Subcutaneous injection
A subcutaneous injection is a method of delivering a medication with a needle that is inserted into the tissue between skin and muscle.
