Why DANYELZA?
DANYELZA is specifically approved for difficult-to-treat HRNB
DANYELZA® is the only FDA-approved option for HRNB in the bone and/or bone marrow specifically for relapsed? or refractory? disease. It targets a glycolipid called GD2?, which is prevalent in neuroblastoma cells and contributes to their growth and survival.
- 10+ years of clinical trial experience
- 65+ administering hospitals
- Approved via FDA’s Accelerated Approval Program, meaning the agency found the early clinical data of DANYELZA to be promising for meeting unmet needs in HRNB
DANYELZA is a humanized immunotherapy?, which means the antibody more closely resembles antibodies produced by the body.
DANYELZA is designed to recognize and attach to GD2, a specific target on your child’s HRNB cancer cells.
With DANYELZA, your child's care team has the flexibility to decide if going home on treatment day is possible. Going home could mean:
Less time spent in the hospital or treatment facility
More time with family and friends in a familiar space
More comforts of home like their favorite toys or art supplies
DANYELZA is NOT chemotherapy or radiation; it is immunotherapy
In HRNB, immunotherapy? works with the body to target and destroy cancer
- DANYELZA is given along with a medicine called granulocyte-macrophage colony-stimulating factor (GM-CSF?)
- GM-CSF? helps produce white blood cells, which strengthens the immune system?
How DANYELZA Works
DANYELZA specifically targets and fights HRNB cells
*Based on studies not conducted in humans.
Going home on treatment day may be possible with DANYELZA
Each DANYELZA treatment cycle is 28 days long, with DANYELZA given intravenously (IV?) by a healthcare professional on Days 1, 3, and 5.
DANYELZA can be given in an outpatient or inpatient setting, at the treating physician's discretion. In clinical trials, most patients were given DANYELZA in an outpatient setting, and many children were able to leave the hospital. Ask your care team to learn more about this possibility.
After at least 2 hours of monitoring following infusion, your doctor can decide if going home is safe—meaning each treatment day could be completed in a morning or afternoon.
Proven Results With DANYELZA
Children with HRNB have reached complete response with DANYELZA
How DANYELZA worked for children with HRNB
DANYELZA®, when used with GM-CSF, showed positive results across 2 clinical studies of children with HRNB who did not fully respond to initial or relapse treatment. Responses were confirmed by at least 1 follow-up scan.
You may know DANYELZA as Hu3F8, the name used in one of the clinical studies.
Results from two clinical trials
Number of children: 38
Primary goal: Overall response rate (ORR)? to treatment with DANYELZA and GM-CSF
*ORR is the portion of children who had partial or complete response to therapy with DANYELZA.
Secondary goal: Duration of response (DOR)?
✝DOR is the amount of time children maintained their complete or partial response, without the cancer growing or spreading.
With DANYELZA, ORR was:
- Defined as partial or complete response to treatment
- Confirmed by at least 1 follow-up scan
Across both studies, more than 1 in 4 children who responded to DANYELZA reached complete response
Additional data from Study 201*
Study 201 continued to enroll patients after approval and a more recent planned analysis was performed. A total number of 52 children were assessed for response.
There were certain limits in this analysis. Though DANYELZA has been shown to help some children, not all children may experience the same results.
The additional analysis of Study 201 also looked at data from patients who had an incomplete response to induction or relapse therapy.
The additional analysis of Study 201 also looked at data from children who had or had not received previous treatment with anti-GD2 medicines. In addition, the analysis collected data for children who had developed anti-drug antibodies (ADAs)?during treatment with DANYELZA.
Among the 18 children who developed ADAs while being treated with DANYELZA, 3 (17%) achieved a complete response ?.
22% of children treated with DANYELZA (4 of 18) developed ADAs while on therapy.
There were certain limits in this analysis. Though DANYELZA has been shown to help some children, not all children may experience the same results.
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.
It is not known if DANYELZA is safe and effective in children younger than 1 year of age.
DANYELZA may cause serious side effects, including:
- swelling of your face, eyes, lips, mouth, or tongue
- itching
- redness on your face (flushing)
- skin rash or hives
- trouble breathing
- cough or wheezing
- noisy high-pitched breathing
- feeling faint or dizziness (low blood pressure)
- weakness in your legs or arms
- bladder and bowel problems
- pain in back, legs, or stomach (abdomen)
- numbness
- tingling
- burning sensation
- severe headache
- vision changes
- changes in mental status, such as confusion, disorientation, or decreased alertness
- difficulty speaking
- weakness in your arms or legs
- seizures
- unequal pupil size
- blurred vision
- trouble focusing your eyes
- larger pupil size (dilated)
- decreased ability to see
- sensitivity to light
- have high blood pressure
- have heart disease
-
are pregnant or plan to become pregnant. DANYELZA may harm your unborn baby.
- your healthcare provider will do a pregnancy test before you start treatment with DANYELZA.
- females who are able to become pregnant should use effective birth control (contraception) during treatment and for 2 months after your last dose of DANYELZA. Talk to your healthcare provider about birth control choices that may be right for you during this time.
- tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with DANYELZA.
- are breastfeeding or plan to breastfeed. It is not known if DANYELZA passes into your breast milk. Do not breastfeed during treatment and for 2 months after your last dose of DANYELZA.
DANYELZA may cause serious side effects, including:
- chest pain
- shortness of breath
- irregular heartbeat or feel like your heart is racing
- headaches
- seizures
- nausea or vomiting
- chest pain
- dizziness
- visual changes
- shortness of breath
- feeling that your heart is pounding or racing (palpitations)
- nose bleeds
- fast heart rate
- vomiting
- cough
- nausea
- decreased white blood cell, red blood cell, and platelet counts
- diarrhea
- decreased appetite
- tiredness
- skin rashes
- decreased level of potassium, sodium, and phosphate in the blood
- hives
- fever
- headache
- injection site reaction
- swelling of the body or only in one part of the body
- anxiety
- irritability
- increased liver function blood tests
- decreased blood sugar level
- decreased calcium levels in the blood
- decreased protein levels (albumin) in the blood
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.
It is not known if DANYELZA is safe and effective in children younger than 1 year of age.
DANYELZA may cause serious side effects, including:
- swelling of your face, eyes, lips, mouth, or tongue
- itching
- redness on your face (flushing)
- skin rash or hives
- trouble breathing
- cough or wheezing
- noisy high-pitched breathing
- feeling faint or dizziness (low blood pressure)
- weakness in your legs or arms
- bladder and bowel problems
- pain in back, legs, or stomach (abdomen)
- numbness
- tingling
- burning sensation
- severe headache
- vision changes
- changes in mental status, such as confusion, disorientation, or decreased alertness
- difficulty speaking
- weakness in your arms or legs
- seizures
- unequal pupil size
- blurred vision
- trouble focusing your eyes
- larger pupil size (dilated)
- decreased ability to see
- sensitivity to light
- have high blood pressure
- have heart disease
-
are pregnant or plan to become pregnant. DANYELZA may harm your unborn baby.
- Your healthcare provider will do a pregnancy test before you start treatment with DANYELZA.
- Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 2 months after your last dose of DANYELZA. Talk to your healthcare provider about birth control choices that may be right for you during this time.
- Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with DANYELZA.
- are breastfeeding or plan to breastfeed. It is not known if DANYELZA passes into your breast milk. Do not breastfeed during treatment and for 2 months after your last dose of DANYELZA.
DANYELZA may cause serious side effects, including:
- chest pain
- shortness of breath
- irregular heartbeat or feel like your heart is racing
- headaches
- seizures
- nausea or vomiting
- chest pain
- dizziness
- visual changes
- shortness of breath
- feeling that your heart is pounding or racing (palpitations)
- nose bleeds
- fast heart rate
- vomiting
- cough
- nausea
- decreased white blood cell, red blood cell, and platelet counts
- diarrhea
- decreased appetite
- tiredness
- skin rashes
- decreased level of potassium, sodium, and phosphate in the blood
- hives
- fever
- headache
- injection site reaction
- swelling of the body or only in one part of the body
- anxiety
- irritability
- increased liver function blood tests
- decreased blood sugar level
- decreased calcium levels in the blood
- decreased protein levels (albumin) in the blood
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.
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