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Description for Danyelza

Naxitamab-gqgk is a glycolipid disialoganglioside (GD2)-binding recombinant humanized monoclonal IgG1 antibody, that contains human framework regions and murine complementarity-determining regions. Naxitamab-gqgk is produced in a Chinese hamster ovary cell line and has an approximate molecular weight of 144 kDa without glycosylation.

DANYELZA (naxitamab-gqgk) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution for intravenous infusion. Each single-dose vial contains 40 mg of naxitamab-gqgk in 10 mL of solution. Each mL of solution contains 4 mg of naxitamab-gqgk, and citric acid anhydrous (0.71 mg), poloxamer 188 (1.5 mg), sodium chloride (7.01 mg), sodium citrate (6.3 mg), and Water for Injection, USP. The pH is approximately 5.7.

ADVERSE REACTIONS

The following clinically significant adverse reactions are also described elsewhere in the labeling:

• Serious Infusion-Related Reactions [see Warnings and Precautions (5.1)]
• Neurotoxicity [see Warnings and Precautions (5.2)]
• Myocarditis [see Warnings and Precautions (5.3)]
• Hypertension [see Warnings and Precautions (5.4)]
• Orthostatic Hypotension [see Warnings and Precautions (5.5)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of DANYELZA in combination with GM-CSF was evaluated in patients with refractory or relapsed high- risk neuroblastoma in bone or bone marrow who had demonstrated a partial response, minor response, or stable disease following initial or subsequent therapy, and in patients who were in second complete remission, from two open-label, single arm studies, Study 201 (n=25) and Study 12-230 (n=72). Patients received DANYELZA 9 mg/kg/cycle administered as three separate intravenous infusions of 3 mg/kg (Day 1, 3 and 5) in the first week of each cycle. Patients also received GM-CSF 250 µg/m2/day subcutaneously on Days -4 to 0 and GM-CSF 500 µg/m2/day subcutaneously on Days 1 to 5 [see Clinical Studies (14)].

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.

Study 201

In Study 201, among 25 patients who received DANYELZA in combination with GM-CSF, 12% were exposed for 6 months or longer and none were exposed for greater than one year.

Serious adverse reactions occurred in 32% of patients who received DANYELZA in combination with GM-CSF. Serious adverse reactions in more than one patient included anaphylactic reaction (12%) and pain (8%). Permanent discontinuation of DANYELZA due to an adverse reaction occurred in 12% of patients. Adverse reactions resulting in permanent discontinuation of DANYELZA included anaphylactic reaction (8%) and respiratory depression (4%).

Dosage interruptions of DANYELZA due to an adverse reaction occurred in 84% of patients. Adverse reactions requiring dosage interruption in > 10% of patients included hypotension and bronchospasm.

Table 4 summarizes adverse reactions in Study 201.

Table 4: Adverse Reactions (>10%) in Patients with Refractory or Relapsed High-Risk Neuroblastoma in Bone or Bone Marrow Who Received DANYELZA with GM-CSF in Study 201

Adverse Reaction	DANYELZA with GM-CSF1 (n=25)
	All Grades (%)	Grade 3 or 4 (%)
Body system
General disorders and administration site conditions
Pain2	100	72
Infusion-related reaction3	100	68
Edema	28	0
Fatigue4	28	0
Pyrexia5	28	0
Respiratory, thoracic and mediastinal disorders
Cough	60	0
Rhinorrhea	24	0
Vascular disorders
Hypertension	44	4
Gastrointestinal disorders
Vomiting	60	4
Diarrhea	56	8
Nausea	56	0
Skin and subcutaneous tissue disorders
Urticaria7	32	4
Cardiac disorders
Tachycardia6	84	4
Nervous system disorders
Peripheral neuropathy8	32	0
Headache	28	8
Depressed level of consciousness	24	16
Eye disorders
Neurological disorders of the eye9	24	0
Immune system disorders
Anaphylactic reaction	12	12
Metabolism and nutrition disorders
Decreased appetite	16	0
Infections and infestations
Influenza	12	0
Rhinovirus infection	12	0
Upper respiratory tract infection	12	0
Investigations
Weight decreased	12	0
Psychiatric disorders
Anxiety	12	0
1 Adverse reactions were graded using CTCAE version 4.0. 2Pain includes pain, abdominal pain, pain in extremity, bone pain, neck pain, back pain, and musculoskeletal pain. 3Infusion-related reaction includes hypotension, bronchospasm, flushing, wheezing, stridor, urticaria, dyspnea, pyrexia, infusion-related reaction, face edema, edema mouth, tongue edema, lip edema, respiratory tract edema, chills, hypoxia, pruritis and rash occurring on the day of infusion or the day following an infusion. 4Fatigue includes fatigue, asthenia. 5Pyrexia not occurring on the day of infusion or the day following an infusion 6Tachycardia includes sinus tachycardia and tachycardia 7Urticaria, not occurring on the day of infusion or the day following an infusion 8Peripheral neuropathy includes peripheral sensory neuropathy, paresthesia, neuralgia. 9Neurological disorders of the eye includes unequal pupils, blurred vision, and mydriasis.

Clinically relevant adverse reactions occurring in ≤10% of patients who received DANYELZA with GM-CSF included peripheral edema (8%).

Table 5 summarizes the laboratory abnormalities in Study 201.

Table 5: Selected Laboratory Abnormalities (>20%) Worsening from Baseline in Patients with Refractory or Relapsed High-Risk Neuroblastoma in Bone or Bone Marrow Who Received DANYELZA with GM-CSF in Study 201

Laboratory Abnormality	DANYELZA with GM-CSF1 n=25
	All Grades (%)	Grade 3 or 4 (%)
Chemistry
Decreased potassium	63	8
Decreased albumin	50	0
Increased alanine aminotransferase	42	8
Decreased sodium	29	0
Hematology
Decreased lymphocytes	74	30
Decreased platelet count	65	17
Decreased neutrophils	61	39
Decreased hemoglobin	48	4
1The table presents laboratory parameters with available grading according to CTCAE 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 one on- study laboratory measurement (range: 23 to 24 patients).

Study 12-230

In Study 12-230, among 72 patients who received DANYELZA in combination with GM-CSF, 32% were exposed for 6 months or longer and 8% were exposed for greater than one year.

Serious adverse reactions occurred in 40% of patients who received DANYELZA in combination with GM-CSF. Serious adverse reactions in > 5% of patients included hypertension (14%), hypotension (11%), and pyrexia (8%). Permanent discontinuation of DANYELZA due to an adverse reaction occurred in 8% of patients. Four (6%) patients permanently discontinued DANYELZA due to hypertension and one (1.4%) patient discontinued due to RPLS.

Table 6 summarizes adverse reactions in Study 12-230.

Table 6: Adverse Reactions (>10%) in Patients with Refractory or Relapsed High-Risk Neuroblastoma in Bone or Bone Marrow Who Received DANYELZA with GM-CSF in Study 12-230

Adverse Reaction	DANYELZA with GM-CSF1,2 (n=72)
	All Grades (%)	Grade 3 or 4 (%)
Body system
General disorders and administration site conditions
Infusion-related reaction3	94	32
Pain4	94	2.8
Fatigue5	44	0
Injection site reaction	28	0
Localized edema	25	0
Pyrexia6	11	0
Vascular disorders
Hypertension	28	7
Gastrointestinal disorders
Vomiting	63	2.8
Nausea	57	1.4
Diarrhea	50	4.2
Constipation	15	0
Skin and subcutaneous tissue disorders
Erythema multiforme	33	0
Hyperhidrosis	17	0
Erythema	11	0
Respiratory, thoracic and mediastinal disorders
Cough	57	0
Oropharyngeal pain	15	0
Rhinorrhea	15	0
Nervous system disorders
Peripheral neuropathy7	25	0
Headache	18	0
Lethargy	14	0
Metabolism and nutrition disorders
Decreased appetite	53	4.2
Cardiac disorders
Sinus tachycardia	44	1.4
Psychiatric disorders
Anxiety	26	0
Irritability	25	0
Investigations
Breath sounds abnormal	15	0
Injury and procedural complications
Contusion	15	0
Infections and infestations
Rhinovirus infection	14	0
Enterovirus infection	13	0
Eye Disorders
Neurological disorders of the eye 8	19	0
1In Study 12-230, all adverse reactions occurring in Cycle 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. 2Adverse reactions were graded using CTCAE version 4.0. 3Infusion-related reaction includes hypotension, bronchospasm, flushing, wheezing, stridor, urticaria, dyspnea, pyrexia, face edema, periorbital edema, lip swelling, swollen tongue, chills, hypoxia, pruritis, rash maculopapular and rash erythematous occurring on the day of infusion or the day following an infusion. 4Pain includes pain, abdominal pain, pain in extremity, bone pain, neck pain, back pain, non-cardiac chest pain, flank pain, and musculoskeletal pain. 5Fatigue includes fatigue, asthenia. 6Pyrexia not occurring on the day of infusion or the day following an infusion. 7Peripheral neuropathy includes peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, neuralgia. 8Neurological disorders of the eye includes unequal pupils, blurred vision, accommodation disorder, visual impairment and photophobia.

Clinically relevant adverse reactions in ≤10% of patients who received DANYELZA with GM-CSF included apnea (4.2%), hypopnea (2.8%), generalized edema (2.8%), peripheral edema (8.3%), and device related infection (4.2%).

Table 7 summarizes the laboratory abnormalities in Study 12-230.

Table 7: Selected Laboratory Abnormalities (>20%) Worsening from Baseline in Patients with Refractory or Relapsed High-Risk Neuroblastoma in Bone or Bone Marrow Who Received DANYELZA with GM-CSF in Study 12-230

Laboratory Abnormality	DANYELZA with GM-CSF1 n=72
	All Grades (%)	Grade 3 or 4 (%)
Chemistry
Increased glucose	74	0
Decreased albumin	68	7
Decreased calcium	64	8
Increased alanine aminotransferase	55	9
Decreased magnesium	54	0
Increased aspartate aminotransferase	49	4
Decreased phosphate	47	5
Decreased potassium	47	32
Decreased sodium	38	6
Decreased glucose	29	8
Hematology
Decreased lymphocytes	79	56
Decreased hemoglobin	76	42
Decreased neutrophils	72	46
Decreased platelets	71	40
1The table presents laboratory parameters with available grading according to CTCAE 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 one on- study laboratory measurement (range 19 to 72 patients).

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of anti-drug antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of anti-drug antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies or to other naxitamab products may be misleading.

In Study 201, 2 of 24 (8%) patients tested positive for anti-drug antibodies (ADA) after treatment with DANYELZA.

In Study 12-230, 27 of 117 patients (23%) tested positive for ADA after treatment with DANYELZA by an assay that was not fully validated; therefore, the incidence of ADA may not be reliable.

Postmarketing Experience/Spontaneous Reports

The following adverse reactions have been identified during expanded access and post-approval use of DANYELZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Neurological: Orthostatic hypotension, Transverse myelitis

Cardiac disorders: Myocarditis

Drug Interactions for Danyelza

No information provided.

Warnings for Danyelza

Included as part of the PRECAUTIONS section.

Precautions for Danyelza

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 [see Adverse Reactions (6.1)].

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-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 2 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.

Caution is advised in patients with pre-existing cardiac disease, as this may exacerbate the risk of severe hypotension.

Premedicate with an antihistamine, acetaminophen, an H2 antagonist and corticosteroid as recommended [see Dosage and Administration (2.2)]. 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 [see Dosage and Administration (2.3) and Contraindications (4)].

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) [see Adverse Reactions (6.1)].

Premedicate with drugs that treat neuropathic pain (e.g., gabapentin) and oral opioids. Administer intravenous opioids as needed for breakthrough pain [see Dosage and Administration (2.2)]. Permanently discontinue DANYELZA based on severity [see Dosage and Administration (2.3)].

Transverse Myelitis

Transverse myelitis has occurred with DANYELZA. Permanently discontinue DANYELZA in patients who develop transverse myelitis [see Dosage and Administration (2.3)].

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 [see Warnings and Precautions (5.3)]. Permanently discontinue DANYELZA in case of symptomatic RPLS [see Dosage and Administration (2.3) and Adverse Reactions (6.1)].

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 [see Adverse Reactions (6.1)].

Permanently discontinue DANYELZA based on severity [see Dosage and Administration (2.3)].

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 [see Dosage and Administration (2.3) and Adverse Reactions (6.1)].

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 [see Dosage and Administration (2.3) and Adverse Reactions (6.1)].

Myocarditis

Myocarditis has occurred in adolescent patients receiving DANYELZA in clinical trials and expanded access programs. Myocarditis occurred within days of receiving DANYELZA requiring drug interruption.

Monitor for signs and symptoms of myocarditis during treatment with DANYELZA. Withhold, reduce the dose, or permanently discontinue DANYELZA based on severity [see Dosage and Administration (2.3)].

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-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 [see Warnings and Precautions (5.2)]. Interrupt DANYELZA infusion and resume at a reduced rate, or permanently discontinue DANYELZA based on the severity [see Dosage and Administration (2.3) and Adverse Reactions (6.1)].

Orthostatic Hypotension

Orthostatic hypotension has occurred in patients receiving DANYELZA in clinical trials and expanded access programs. Severe orthostatic hypotension, including cases requiring hospitalization, have occurred. Cases occurred within hours to 6 days of DANYELZA infusions in any cycle.

In patients with symptoms of orthostatic hypotension, monitor postural blood pressure prior to initiating treatment with DANYELZA and as clinically indicated with subsequent dosing. Withhold, reduce dose, or permanently discontinue DANYELZA based on severity [see Dosage and Administration (2.3)].

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 last dose. [see Use in Specific Populations (8.1, 8.3)].

NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies have been conducted to evaluate the carcinogenic or mutagenic potential of naxitamab-gqgk. Dedicated studies evaluating the effects of naxitamab-gqgk on fertility in animals have not been conducted.

OVERDOSES

No information provided.

Contraindications for Danyelza

DANYELZA is contraindicated in patients with a history of severe hypersensitivity reaction to naxitamab-gqgk. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)].

Clinical Pharmacology for Danyelza

Mechanism Of Action

Naxitamab-gqgk binds to the glycolipid GD2. GD2 is a disialoganglioside that is overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves. In vitro, naxitamab-gqgk was able to bind to cell surface GD2 and induce complement dependent cytotoxicity (CDC) and antibody dependent cell-mediated cytotoxicity (ADCC).

Pharmacodynamics

The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of naxitamab-gqgk have not been fully characterized.

Pharmacokinetics

The geometric mean (CV%) maximum plasma concentration (Cmax) of naxitamab-gqgk was 57.4 µg/mL (49%) following DANYELZA 3 mg/kg intravenous infusion over 30 minutes.

Elimination

The mean terminal half-life of naxitamab-gqgk was 8.2 days.

Metabolism

Naxitamab-gqgk is expected to be metabolized into small peptides by catabolic pathways.

Specific Populations

Population pharmacokinetic analyses suggest that age (range: 1 to 34 years), sex and race have no clinically important effect on the clearance (CL) of naxitamab-gqgk. The naxitamab-gqgk systemic exposure (AUC) at 150 mg/day (450 mg per cycle) for patients with body weight over 50 kg is not expected to differ clinically from that of the naxitamab- gqgk exposures at 3 mg/kg/day (9 mg/kg per cycle) for patients with body weight of 30 - 50 kg.

Animal Toxicology and/or Pharmacology

Non-clinical studies suggest that naxitamab-gqgk-induced neuropathic pain is mediated by binding of the antibody to the GD2 antigen located on the surface of peripheral nerve fibers and myelin and subsequent induction of immune- mediated cytotoxic activity.

In a nude rat model, slight-moderate hyperplasia and erosion of the glandular mucosa of the stomach occurred, occasionally accompanied by diffuse inflammation. Complete recovery of all histopathological findings in the stomachs of male rats was observed; however, only partial recovery was observed in the stomachs of female rats during the four week off-drug period.

Patient Information for Danyelza

Advise the patient and caregiver to read the FDA-approved patient labeling (Patient Information).

Serious Infusion-Related Reactions

Advise patients and caregivers that DANYELZA can cause serious infusion-related reactions and anaphylaxis and to immediately report any signs or symptoms, such as facial or lip swelling, urticaria, or difficulty breathing, that occur during or following the infusion [see Warnings and Precautions (5.1)].

Neurotoxicity

Advise patients and caregivers that DANYELZA can cause neurotoxicity, including severe pain, peripheral neuropathy, neurological disorders of the eye, prolonged urinary retention, transverse myelitis, and reverse posterior leukoencephalopathy syndrome. Advise patients to contact their healthcare provider for any new or worsening neurological symptoms [see Warnings and Precautions (5.2)].

Myocarditis

Advise patients and caregivers that myocarditis has been seen in patients taking DANYELZA and to report any signs or symptoms, such as chest pain, shortness of breath or abnormal heart rhythms during treatment with DANYELZA [see Warnings and Precautions (5.3)].

Hypertension

Advise patients and caregivers that DANYELZA can cause hypertension and to immediately report signs or symptoms of hypertension [see Warnings and Precautions (5.4)].

Orthostatic Hypotension

Advise patients and caregivers that DANYELZA can cause severe low blood pressure when standing after sitting or lying down. Advise patients and caregivers to report any signs or symptoms, such as dizziness, lightheadedness or fainting during treatment with DANYELZA [see Warnings and Precautions (5.5)].

Embryo-Fetal Toxicity

[see Warnings and Precautions (5.6) and Use in Specific Populations (8.1, 8.3)]. Advise females of reproductive potential, including pregnant women, of the potential risk to the fetus.

Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy and

to use effective contraception during treatment with and for 2 months after the last dose of DANYELZA.

Lactation

Advise women not to breastfeed during treatment with DANYELZA and for 2 months after the last dose [see Use in Specific Populations (8.2)].

DANYELZA® is a registered trademark of Y-mAbs Therapeutics, Inc.

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Manufactured by:
Y-mAbs Therapeutics, Inc
202 Carnegie Center, Suite 301
Princeton, NJ 08540
U.S. License No. 2209