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DANYELZA® with GM-CSF: Pooled Safety Results | DANYELZA
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Safety analysis of patients who received DANYELZA® with GM-CSF

DANYELZA can cause serious infusion reactions, including hypotension, bronchospasm, hypoxia, and stridor, as well as severe neurotoxicity, including pain1:

bottom arrowAny grade infusion-related reactions occurred in 94%−100% of patients

  • — Any grade hypotension occurred in 89%−100% of patients

bottom arrowAny grade pain occurred in 94%−100% of patients

The most common ARs in Studies 201 and 12-230 (≥25% in either study)1
  • bottom arrowInfusion-related reaction
  • bottom arrowPain
  • bottom arrowTachycardia
  • bottom arrowVomiting
  • bottom arrowCough
  • bottom arrowNausea
  • bottom arrowDiarrhea
  • bottom arrowDecreased appetite
  • bottom arrowHypertension
  • bottom arrowFatigue
  • bottom arrowErythema multiforme
  • bottom arrowPeripheral neuropathy
  • bottom arrowUrticaria
  • bottom arrowPyrexia
  • bottom arrowHeadache
  • bottom arrowInjection site reaction
  • bottom arrowEdema
  • bottom arrowAnxiety
  • bottom arrowLocalized edema
  • bottom arrowIrritability
Total DANYELZA exposure across Studies 201 and 12-2301,2

bottom arrowOf the 25 patients in Study 201, an ongoing multicenter trial, 12% were exposed to DANYELZA with GM-CSF for ≥6 months and 0% for >1 year

bottom arrowOf the 72 patients in Study 12-230, 32% were exposed to DANYELZA with GM-CSF for ≥6 months and 8% for >1 year

STUDY 201 (n=25)
STUDY 12-2301 (n=72)

Adverse Reaction

All Grades

Grade 3 or 4

All Grades

Grade 3 or 4

System organ class/preferred term

%

%

%

%

General disorders and administration site conditions

Pain2

Infusion-related reaction3

Edema

Fatigue4

Pyrexia5

Injection site reaction

Localized edema

100%

100%

28%

28%

28%

N/A

N/A

68%

72%

0%

0%

0%

N/A

N/A

94%

94%

N/A

44%

11%

28%

25%

32%

2.8%

N/A

0%

0%

0%

0%

Respiratory, thoracic, and mediastinal disorders

Cough

Rhinorrhea

Oropharyngeal pain

60%

24%

N/A

0%

0%

N/A

57%

15%

15%

0%

0%

0%

Vascular disorders

Hypertension

44%

4%

28%

7%

Gastrointestinal disorders

Vomiting

Diarrhea

Nausea

Constipation

60%

56%

56%

N/A

4%

8%

0%

N/A

63%

50%

57%

15%

2.8%

4.2%

1.4%

0%

Skin and subcutaneous tissue disorders

Urticaria6

Erythema multiforme

Hyperhidrosis

Erythema

32%

N/A

N/A

N/A

4%

N/A

N/A

N/A

N/A

33%

17%

11%

N/A

0%

0%

0%

Cardiac disorders

Tachycardia7

Sinus tachycardia

84%

N/A

4%

N/A

N/A

44%

N/A

1.4%

Nervous system disorders

Peripheral neuropathy8

Headache

Depressed level of consciousness

Lethargy

32%

28%

24%

N/A

0%

8%

16%

N/A

25%

18%

N/A

14%

0%

0%

N/A

0%

Eye disorders

Neurological disorders of the eye9

24%

0%

19%

0%

Immune system disorders

Anaphylactic reaction

12%

12%

N/A

0%

Metabolism and nutrition disorders

Decreased appetite

16%

0%

53%

4.2%

Infections and infestations

Influenza

Rhinovirus infection

Upper respiratory tract infection

Enterovirus infection

12%

12%

12%

N/A

0%

0%

0%

N/A

N/A

14%

N/A

13%

N/A

0%

N/A

0%

Investigations

Weight decreased

Breath sounds abnormal

12%

N/A

0%

N/A

N/A

15%

N/A

0%

Psychiatric disorders

Anxiety

Irritability

12%

N/A

0%

N/A

26%

25%

0%

0%

Injury and procedural complications

Contusion

N/A

N/A

15%

0%

Adverse
Reaction

All Grades

Grade 3 or 4

All Grades

Grade 3 or 4

System organ class/preferred term

%

%

%

%

General disorders and administration site conditions

Pain2

Infusion-related reaction3

Edema

Fatigue4

Pyrexia5

Injection site reaction

Localized edema

100%

100%

28%

28%

28%

N/A

N/A

68%

72%

0%

0%

0%

N/A

N/A

94%

94%

N/A

44%

11%

28%

25%

2.8%

32%

N/A

0%

0%

0%

0%

Respiratory, thoracic, and mediastinal disorders

Cough

Rhinorrhea

Oropharyngeal pain

60%

24%

N/A

0%

0%

N/A

57%

15%

15%

0%

0%

0%

Vascular disorders

Hypertension

44%

4%

28%

7%

Gastrointestinal disorders

Vomiting

Diarrhea

Nausea

Constipation

60%

56%

56%

N/A

4%

8%

0%

N/A

63%

50%

57%

15%

2.8%

4.2%

1.4%

0%

Skin and subcutaneous tissue disorders

Urticaria6

Erythema multiforme

Hyperhidrosis

Erythema

32%

N/A

N/A

N/A

4%

N/A

N/A

N/A

N/A

33%

17%

11%

N/A

0%

0%

0%

Cardiac disorders

Tachycardia7

Sinus tachycardia

84%

N/A

4%

N/A

N/A

44%

N/A

1.4%

Nervous system disorders

Peripheral neuropathy8

Headache

Depressed level of consciousness

Lethargy

32%

28%

24%

N/A

0%

8%

16%

N/A

25%

18%

N/A

14%

0%

0%

N/A

0%

Eye disorders

Neurological disorders of the eye

24%

0%

19%

0%

Immune system disorders

Anaphylactic reaction

12%

12%

N/A

0%

Metabolism and nutrition disorders

Decreased appetite

16%

0%

53%

4.2%

Infections and infestations

Influenza

Rhinovirus infection

Upper respiratory tract infection

Enterovirus infection

12%

12%

12%

N/A

0%

0%

0%

N/A

N/A

14%

N/A

13%

N/A

0%

N/A

0%

Investigations

Weight decreased

Breath sounds abnormal

12%

N/A

0%

N/A

N/A

15%

N/A

0%

Psychiatric disorders

Anxiety

Irritability

12%

N/A

0%

N/A

26%

25%

0%

0%

Injury and procedural complications

Contusion

N/A

N/A

15%

0%

Adverse
Reaction

All Grades

Grade 3 or 4

All Grades

Grade 3 or 4

System organ class/preferred term

%

%

%

%

General disorders and administration site conditions

Pain2

Infusion-related reaction3

Edema

Fatigue4

Pyrexia5

Injection site reaction

Localized edema

100%

100%

28%

28%

28%

N/A

N/A

68%

72%

0%

0%

0%

N/A

N/A

94%

94%

N/A

44%

11%

28%

25%

32%

2.8%

N/A

0%

0%

0%

0%

Respiratory, thoracic, and mediastinal disorders

Cough

Oropharyngeal pain

Rhinorrhea

60%

24%

N/A

0%

0%

N/A

57%

15%

15%

0%

0%

0%

Vascular disorders

Hypertension

44%

4%

28%

7%

Gastrointestinal disorders

Vomiting

Diarrhea

Nausea

Constipation

60%

56%

56%

N/A

4%

8%

0%

N/A

63%

50%

57%

15%

2.8%

4.2%

1.4%

0%

Skin and subcutaneous tissue disorders

Urticaria6

Erythema multiforme

Hyperhidrosis

Erythema

32%

N/A

N/A

N/A

4%

N/A

N/A

N/A

N/A

33%

17%

11%

N/A

0%

0%

0%

Cardiac disorders

Tachycardia7

Sinus tachycardia

84%

N/A

4%

N/A

N/A

44%

N/A

1.4%

Nervous system disorders

Peripheral neuropathy8

Headache

Depressed level of consciousness

Lethargy

32%

28%

24%

N/A

0%

8%

16%

N/A

25%

18%

N/A

14%

0%

0%

N/A

0%

Eye disorders

Neurological disorders of the eye

24%

0%

19%

0%

Immune system disorders

Anaphylactic reaction

12%

12%

N/A

0%

Metabolism and nutrition disorders

Decreased appetite

16%

0%

53%

4.2%

Infections and infestations

Influenza

Rhinovirus infection

Upper respiratory tract infection

Enterovirus infection

12%

12%

12%

N/A

0%

0%

0%

N/A

N/A

14%

N/A

13%

N/A

0%

N/A

0%

Investigations

Weight decreased

Breath sounds abnormal

12%

N/A

0%

N/A

N/A

15%

N/A

0%

Psychiatric disorders

Anxiety

Decreased appetite

12%

N/A

0%

N/A

26%

25%

0%

0%

Injury and procedural complications

Contusion

N/A

N/A

15%

0%

Adverse reactions were graded using Common Terminology Criteria for Adverse Events version 4.0. 1All adverse reactions occurring in Cycles 1 and 2, and adverse reactions of Grade ≥3 severity occurring in subsequent cycles were reported. In the dose-finding phase, Grade 2 unexpected adverse reactions were also reported for Cycles 3 and later. 2Pain includes pain, abdominal pain, pain in extremity, bone pain, neck pain, back pain, non-cardiac chest pain, flank pain, and musculoskeletal pain. 3Infusion-related reaction includes hypotension, bronchospasm, flushing, wheezing, stridor, urticaria, dyspnea, pyrexia, infusion-related reaction, face edema, edema mouth, periorbital edema, lip swelling, swollen tongue, tongue edema, lip edema, respiratory tract edema, chills, hypoxia, pruritus, rash, rash maculo-papular, and rash erythematous occurring on the day of infusion or the day following an infusion. 4Fatigue includes fatigue and asthenia. 5Pyrexia not occurring on the day of infusion or the day following an infusion. 6Urticaria, not occurring on the day of infusion or the day following an infusion. 7Tachycardia includes sinus tachycardia and tachycardia. 8Peripheral neuropathy includes peripheral sensory neuropathy, paresthesia, neuralgia. 9Neurological disorders of the eye includes unequal pupils, blurred vision, and mydriasis.
N/A=not applicable.

STUDY 2011 (n=25)
STUDY 12-2302 (n=72)

Laboratory Abnormality

All Grades

%

Grade 3 or 4

%

All Grades

%

Grade 3 or 4

%

Chemistry

Decreased potassium

Decreased albumin

Increased alanine aminotransferase

Decreased sodium

Increased glucose

Decreased calcium

Decreased magnesium

Increased aspartate aminotransferase

Decreased phosphate

Decreased glucose

63%

50%

42%

29%

N/A

N/A

N/A

N/A

N/A

N/A

8%

0%

8%

0%

N/A

N/A

N/A

N/A

N/A

N/A

47%

68%

55%

38%

74%

64%

54%

49%

47%

29%

32%

7%

9%

6%

0%

8%

0%

4%

5%

8%

Hematology

Decreased lymphocytes

Decreased platelet count

Decreased neutrophils

Decreased hemoglobin

74%

65%

61%

48%

30%

17%

39%

4%

79%

71%

72%

76%

56%

40%

46%

42%

Laboratory Abnormality

All Grades

%

Grade 3 or 4

%

All Grades

Grade 3 or 4

%

%

%

%

Chemistry

Decreased potassium

Decreased albumin

Increased alanine aminotransferase

Decreased sodium

Increased glucose

Decreased calcium

Decreased magnesium

Increased aspartate aminotransferase

Decreased phosphate

Decreased glucose

63%

50%

42%

29%

N/A

N/A

N/A

N/A

N/A

N/A

8%

0%

8%

0%

N/A

N/A

N/A

N/A

N/A

N/A

47%

68%

55%

38%

74%

64%

54%

49%

47%

29%

32%

7%

9%

6%

0%

8%

0%

4%

5%

8%

Hematology

Decreased lymphocytes

Decreased platelet count

Decreased neutrophils

Decreased hemoglobin

74%

65%

61%

48%

30%

17%

39%

4%

79%

71%

72%

76%

56%

40%

46%

42%

Laboratory Abnormality

All Grades

Grade 3 or 4

All Grades

%

Grade 3 or 4

%

%

%

%

%

Chemistry

Decreased potassium

Decreased albumin

Increased alanine aminotransferase

Decreased sodium

Increased glucose

Decreased calcium

Decreased magnesium

Increased aspartate aminotransferase

Decreased phosphate

Decreased glucose

63%

50%

42%

29%

N/A

N/A

N/A

N/A

N/A

N/A

8%

0%

8%

0%

N/A

N/A

N/A

N/A

N/A

N/A

47%

68%

55%

38%

74%

64%

54%

49%

47%

29%

32%

7%

9%

6%

0%

8%

0%

4%

5%

8%

Hematology

Decreased lymphocytes

Decreased platelet count

Decreased neutrophils

Decreased hemoglobin

74%

65%

61%

48%

30%

17%

39%

4%

79%

71%

72%

76%

56%

40%

46%

42%

The table presents laboratory parameters with available grading according to Common Terminology Criteria for Adverse Events version 4.0. Baseline evaluation was the last non-missing value prior to first DANYELZA dosing. Each test incidence is based on the number of patients who had both a baseline value and at least 1 on-study laboratory measurement. 1Range: 23 to 24 patients. 2Range: 19 to 72 patients.
N/A=not applicable.

DStudy 201 serious adverse reactions chart DANYELZA-Study 201-serious-adverse-reactions

• Dose interruptions due to an AR occurred in 84% of patients. ARs requiring dosage interruption in >10% of patients included hypotension and bronchospasm1

*Serious ARs occurring in only 1 patient.
AR=adverse reaction.

Study 12-230 serious adverse reactions chart DANYELZA-Study-12-230-serious-adverse-reactions

*Serious ARs occurring in <5% of patients.
AR=adverse reaction; RPLS=reversible posterior leukoencephalopathy syndrome.

Infusion-related reactions

bottom arrowGrade 4, Grade 3 and not responding to medical intervention, or Grade 3-4 anaphylaxis

Neurological disorders of the eye

bottom arrowGrade 2-4 not resolving within 2 weeks or upon recurrence; any grade with subtotal or total vision loss

Pain

bottom arrowGrade 3 and unresponsive to maximum supportive measures

Prolonged urinary retention

bottom arrowPersisting following discontinuation of opioids

Reversible posterior leukoencephalopathy syndrome (RPLS)

bottom arrowAll grades

Hypertension

bottom arrowGrade 4, or Grade 3 and not responding to medical intervention

Transverse myelitis

bottom arrowAll grades

Other ARs

bottom arrowGrade 4, or Grade 3 not resolving to Grade ≤2 within 2 weeks

Peripheral neuropathy

bottom arrowGrade ≥2 motor neuropathy or Grade 3-4 sensory neuropathy

Infusion-related reactions

bottom arrowGrade 4, Grade 3 and not responding to medical intervention, or Grade 3-4 anaphylaxis

Pain

bottom arrowGrade 3 and unresponsive to maximum supportive measures

Reversible posterior leukoencephalopathy syndrome (RPLS)

bottom arrowAll grades

Transverse myelitis

bottom arrowAll grades

Peripheral neuropathy

bottom arrowGrade ≥2 motor neuropathy or Grade 3-4 sensory neuropathy

Neurological disorders of the eye

bottom arrowGrade 2-4 not resolving within 2 weeks or upon recurrence; any grade with subtotal or total vision loss

Prolonged urinary retention

bottom arrowPersisting following discontinuation of opioids

Hypertension

bottom arrowGrade 4, or Grade 3 and not responding to medical intervention

Other ARs

bottom arrowGrade 4, or Grade 3 not resolving to Grade ≤2 within 2 weeks

†Based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
AR=adverse reaction.

An expert in pediatric oncology reviews important DANYELZA information

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Study Results Dosing and Administration
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INDICATION

DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partiaI response, minor response, or stable disease to prior therapy.

This indication is approved under accelerated approval based on overalI response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

CONTRAINDICATION

DANYELZA is contraindicated in patients with a history of severe hypersensitivity reaction to naxitamab-gqgk. Reactions have included anaphylaxis.

WARNINGS AND PRECAUTIONS
Serious Infusion-Related Reactions

DANYELZA can cause serious infusion reactions requiring urgent intervention including fluid resuscitation, administration of bronchodilators and corticosteroids, intensive care unit admission, infusion rate reduction or interruption of DANYELZA infusion. Infusion-related reactions included hypotension, bronchospasm, hypoxia, and stridor.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY

Serious Infusion-Related Reactions

  • DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. lnfusion reactions of any Grade occurred in 94-100% of patients. Severe infusion reactions occurred in 32-68% and serious infusion reactions occurred in 4-18% of patients in DANYELZA clinical studies.
  • Premedicate prior to each DANYELZA infusion as recommended and monitor patients for at least 2 hours following completion of each infusion. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity.

    • Neurotoxicity

  • DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis and reversible posterior leukoencephalopathy syndrome (RPLS). Pain of any Grade occurred in 94-100% of patients in DANYELZA clinical studies.
  • Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity.
CONTRAINDICATION

DANYELZA is contraindicated in patients with a history of severe hypersensitivity reaction to naxitamab-gqgk. Reactions have included anaphylaxis.

WARNINGS AND PRECAUTIONS
Serious Infusion-Related Reactions

DANYELZA can cause serious infusion reactions requiring urgent intervention including fluid resuscitation, administration of bronchodilators and corticosteroids, intensive care unit admission, infusion rate reduction or interruption of DANYELZA infusion. Infusion-related reactions included hypotension, bronchospasm, hypoxia, and stridor.

Serious infusion-related reactions occurred in 4% of patients in Study 201 and in 18% of patients in Study 12-230. Infusion-related reactions of any Grade occurred in 100% of patients in Study 201 and 94% of patients in Study 12-230. Hypotension of any grade occurred in 100% of patients in Study 201 and 89% of patients in Study 12-230.

In Study 201, 68% of patients experienced Grade 3 or 4 infusion reactions; and in Study 12-230, 32% of patients experienced Grade 3 or 4 infusion reactions. Anaphylaxis occurred in 12% of patients and two patients (8%) permanently discontinued DANYELZA due to anaphylaxis in Study 201. One patient in Study 12-230 (1.4%) experienced a Grade 4 cardiac arrest 1.5 hours following completion of DANYELZA infusion.

In Study 201, infusion reactions generally occurred within 24 hours of completing a DANYELZA infusion, most often within 30 minutes of initiation. Infusion reactions were most frequent during the first infusion of DANYELZA in each cycle. Eighty percent of patients required reduction in infusion rate and 80% of patients had an infusion interrupted for at least one infusion-related reaction.

Premedicate with an antihistamine, acetaminophen, an H2 antagonist and corticosteroid as recommended. Monitor patients closely for signs and symptoms of infusion reactions during and for at least 2 hours following completion of each DANYELZA infusion in a setting where cardiopulmonary resuscitation medication and equipment are available.

Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity and institute appropriate medical management as needed.

Neurotoxicity

DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome.

Pain
Pain, including abdominal pain, bone pain, neck pain, and extremity pain, occurred in 100% of patients in Study 201 and 94% of patients in Study 12-230. Grade 3 pain occurred in 72% of patients in Study 201. One patient in Study 201 (4%) required interruption of an infusion due to pain. Pain typically began during the infusion of DANYELZA and lasted a median of less than one day in Study 201 (range less than one day and up to 62 days).

Premedicate with drugs that treat neuropathic pain (e.g., gabapentin) and oral opioids. Administer intravenous opioids as needed for breakthrough pain. Permanently discontinue DANYELZA based on severity.

Transverse Myelitis
Transverse myelitis has occurred with DANYELZA. Permanently discontinue DANYELZA in patients who develop transverse myelitis.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Reversible posterior leukoencephalopathy syndrome (RPLS) (also known as posterior reversible encephalopathy syndrome or PRES) occurred in 2 (2.8%) patients in Study 12-230. Events occurred 2 and 7 days following completion of the first cycle of DANYELZA. Monitor blood pressure during and following DANYELZA infusion and assess for neurologic symptoms. Permanently discontinue DANYELZA in case of symptomatic RPLS.

Peripheral Neuropathy
Peripheral neuropathy, including peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, and neuralgia, occurred in 32% of patients in Study 201 and in 25% of patients in Study 12-230. Most signs and symptoms of neuropathy began on the day of the infusion and neuropathy lasted a median of 5.5 days (range 0 to 22 days) in Study 201 and 0 days (range 0 to 22 days) in Study 12-230.

Permanently discontinue DANYELZA based on severity.

Neurological Disorders of the Eye
Neurological disorders of the eye including unequal pupils, blurred vision, accommodation disorder, mydriasis, visual impairment, and photophobia occurred in 24% of patients in Study 201 and 19% of patients in Study 12-230. Neurological disorders of the eye lasted a median of 17 days (range 0 to 84 days) in Study 201 with two patients (8%) experiencing an event that had not resolved at the time of data cutoff, and a median of 1 day (range less than one day to 21 days) in Study 12-230. Permanently discontinue DANYELZA based on severity.

Prolonged Urinary Retention
Urinary retention occurred in 1 (4%) patient in Study 201 and in 3 patients (4%) in Study 12-230. All events in both studies occurred on the day of an infusion of DANYELZA and lasted between 0 and 24 days. Permanently discontinue DANYELZA in patients with urinary retention that does not resolve following discontinuation of opioids.

Hypertension

Hypertension occurred in 44% of patients in Study 201 and 28% of patients in Study 12-230 who received DANYELZA. Grade 3 or 4 hypertension occurred in 4% of patients in Study 201 and 7% of patients in Study 12-230. Four patients (6%) in Study 12-230 permanently discontinued DANYELZA due to hypertension. In both studies, most events occurred on the day of DANYELZA infusion and occurred up to 9 days following an infusion of DANYELZA.

Do not initiate DANYELZA in patients with uncontrolled hypertension. Monitor blood pressure during infusion, and at least daily on Days 1 to 8 of each cycle of DANYELZA and evaluate for complications of hypertension including RPLS. Interrupt DANYELZA infusion and resume at a reduced rate, or permanently discontinue DANYELZA based on the severity.

Embryo-Fetal Toxicity

Based on its mechanism of action, DANYELZA may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential, including pregnant women, of the potential risk to a fetus. Advise females of reproductive potential to use effective contraceptive during treatment with DANYELZA and for two months after the final dose.

ADVERSE REACTIONS

The most common adverse reactions in Studies 201 and 12-230 (≥25% in either study) were infusion-related reaction, pain, tachycardia, vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reaction, edema, anxiety, localized edema and irritability. The most common Grade 3 or 4 laboratory abnormalities (≥5% in either study) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased platelet count, decreased potassium, increased alanine aminotransferase, decreased glucose, decreased calcium, decreased albumin, decreased sodium and decreased phosphate.

Please see full Prescribing Information and Patient Information for DANYELZA including Boxed Warning on serious infusion-related reactions and neurotoxicity.

Reference: 1. DANYELZA® [package insert]. New York, NY: Y-mAbs Therapeutics, Inc.; 2020. Available online at https://labeling.ymabs.com/danyelza.

References: 1. DANYELZA® [package insert]. New York, NY: Y-mAbs Therapeutics, Inc.; 2020. Available online at https://labeling.ymabs.com/danyelza. 2. Cheung N-K V, Guo H, Hu J, Tassev DV, Cheung IY. Humanizing murine IgG3 anti-GD2 antibody m3F8 substantially improves antibody-dependent cell-mediated cytotoxicity while retaining targeting in vivo. Oncoimmunology. 2012;1(4):477-486. 3. Nazha B, Inal C, Owonikoko TK. Disialoganglioside GD2 expression in solid tumors and role as a target for cancer therapy. Front Oncol. 2020;10:1-15.

References: 1. Data on file. Y-mAbs Therapeutics, Inc. 2. DANYELZA® [package insert]. New York, NY: Y-mAbs Therapeutics, Inc.; 2020. Available online at https://labeling.ymabs.com/danyelza. 3. Smith V, Foster J. High-risk neuroblastoma treatment review. Children (Basel). 2018;5(9):114. 4. Ahmed A, Zhang L, Reddivalla N, Hetherington M. Neuroblastoma in children: update on clinicopathologic and genetic prognostic factors. Pediatr Hematol Oncol. 2017;34(3):165-185. 5. London W, Castel V, Monclair T, et al. Clinical and biologic features predictive of survival after relapse of neuroblastoma: a report from International Neuroblastoma Risk Group project. J Clin Oncol. 2011;29(24):3286-3292.

References: 1. DANYELZA® [package insert]. New York, NY: Y-mAbs Therapeutics, Inc.; 2020. Available online at https://labeling.ymabs.com/danyelza. 2. Data on file. Y-mAbs Therapeutics, Inc.

References: 1. DANYELZA® [package insert]. New York, NY: Y-mAbs Therapeutics, Inc.; 2020. Available online at https://labeling.ymabs.com/danyelza. 2. National Cancer Institute. Published November 27, 2017. Accessed May 17, 2021. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf

References:  1. DANYELZA® [package insert]. New York, NY: Y-mAbs Therapeutics, Inc.; 2020. Available online at https://labeling.ymabs.com/danyelza. 2. Data on file. Y-mAbs Therapeutics, Inc.

References: 1. DANYELZA® [package insert]. New York, NY: Y-mAbs Therapeutics, Inc.; 2020. Available online at https://labeling.ymabs.com/danyelza. 2. Data on file. Y-mAbs Therapeutics, Inc.

References: 1. DANYELZA® [package insert]. New York, NY: Y-mAbs Therapeutics, Inc.; 2020. Available online at https://labeling.ymabs.com/danyelza. 2. Data on file. Y-mAbs Therapeutics, Inc.

INDICATION View all

DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partiaI response, minor response, or stable disease to prior therapy.

This indication is approved under accelerated approval based on overalI response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

CONTRAINDICATION

DANYELZA is contraindicated in patients with a history of severe hypersensitivity reaction to naxitamablqgk. Reactions have included anaphylaxis.

WARNINGS AND PRECAUTIONS

Serious Infusion-Related Reactions

DANYELZA can cause serious infusion reactions requiting urgent intervention including fluid resuscitation, administration of bronchodilators and corticosteroids, intensive care unit admission, infusion rate reduction or interruption of DANYELZA infusion. Infusion-related reactions included hypotension, bronchospasm, hypoxia, and stridor.

IMPORTANT SAFETY INFORMATION View all
IMPORTANT SAFETY INFO View all

WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY

Serious Infusion-Related Reactions

  • DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. lnfusion reactions of any Grade occurred in 94-100% of patients. Severe infusion reactions occurred in 32-68% and serious infusion reactions occurred in 4-18% of patients in DANYELZA clinical studies.
  • Premedicate prior to each DANYELZA infusion as recommended and monitor patients for at least 2 hours following completion of each infusion. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity.

  • Neurotoxicity

    DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Pain of any Grade occurred in 94-100% of patients in DANYELZA clinical studies.
  • Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity.