Unituxin Drug Information

Generic name: DINUTUXIMAB

Glycolipid Disialoganglioside-directed Antibody [EPC]

Save on Unituxin at your pharmacy Compare prices near you and start saving today—no enrollment required.

Uses of Unituxin

Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Dosage & Administration of Unituxin

Instructions for Preparation and Administration Preparation

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light by storing in the outer carton. DO NOT FREEZE OR SHAKE vials.

Inspect visually for particulate matter and discoloration prior to administration. Do not administer Unituxin and discard the single-dose vial if the solution is cloudy, has pronounced discoloration, or contains particulate matter. Aseptically withdraw the required volume of Unituxin from the single-dose vial and inject into a 100-mL bag of 0.9% Sodium Chloride Injection, USP.

Mix by gentle inversion. Do not shake. Discard unused contents of the vial.

Store the diluted Unituxin solution under refrigeration (2°C to 8°C). Initiate infusion within 4 hours of preparation. Discard diluted Unituxin solution 24 hours after preparation.

Administration Administer Unituxin as a diluted intravenous infusion only. Do not administer Unituxin as an intravenous push or bolus.

Table 1: Schedule of Unituxin Administration for Cycles 1, 3, and 5
Cycle Day	1 through 3	4	5	6	7	8 through 24 Cycles 1, 3, and 5 are 24 days in duration.
Unituxin		X	X	X	X

Table 2: Schedule of Unituxin Administration for Cycles 2 and 4
Cycle Day	1 through 7	8	9	10	11	12 through 32 Cycles 2 and 4 are 32 days in duration.
Unituxin		X	X	X	X

Table 4: Dose Modification for Selected Unituxin Adverse Reactions
Infusion-related reactions [see Warnings and Precautions (5.1) ]
Mild to moderate adverse reactions, such as transient rash, fever, rigors, and localized urticaria, that respond promptly to symptomatic treatment
Onset of reaction:	Reduce Unituxin infusion rate to 50% of the previous rate and monitor closely.
After resolution:	Gradually increase infusion rate up to a maximum rate of 1.75 mg/m 2 /hour.
Prolonged or severe adverse reactions, such as mild bronchospasm without other symptoms, or angioedema that does not affect the airway
Onset of reaction:	Immediately interrupt Unituxin.
After resolution:	If signs and symptoms resolve rapidly, resume Unituxin at 50% of the previous rate and observe closely.
First recurrence:	Discontinue Unituxin until the following day. If symptoms resolve and continued treatment is warranted, premedicate with hydrocortisone 1 mg/kg (maximum dose 50 mg) intravenously and administer Unituxin at a rate of 0.875 mg/m 2 /hour in an intensive care unit.
Second recurrence:	Permanently discontinue Unituxin.
Neurological disorders of the eye [see Warnings and Precautions (5.2) ]
Onset of reaction:	Discontinue Unituxin infusion until resolution.
After resolution:	Reduce the Unituxin dose by 50%.
First recurrence or if accompanied by visual impairment:	Permanently discontinue Unituxin.
Capillary leak syndrome [see Warnings and Precautions (5.3) ]
Moderate to severe but not life-threatening capillary leak syndrome
Onset of reaction:	Immediately interrupt Unituxin.
After resolution:	Resume Unituxin infusion at 50% of the previous rate.
Life-threatening capillary leak syndrome
Onset of reaction:	Discontinue Unituxin for the current cycle.
After resolution:	In subsequent cycles, administer Unituxin at 50% of the previous rate.
First recurrence:	Permanently discontinue Unituxin.
Hypotension Symptomatic hypotension, systolic blood pressure (SBP) less than lower limit of normal for age, or SBP decreased by more than 15% compared to baseline. requiring medical intervention [see Warnings and Precautions (5.4) ]
Onset of reaction:	Interrupt Unituxin infusion.
After resolution:	Resume Unituxin infusion at 50% of the previous rate. If blood pressure remains stable for at least 2 hours, increase the infusion rate as tolerated up to a maximum rate of 1.75 mg/m 2 /hour.
Severe systemic infection or sepsis [see Warnings and Precautions (5.5) ]
Onset of reaction:	Discontinue Unituxin until resolution of infection, and then proceed with subsequent cycles of therapy.

Side Effects of Unituxin

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 rates observed in clinical practice. The data described below reflect exposure to Unituxin at the recommended dose and schedule in 1021 patients with high-risk neuroblastoma enrolled in an open-label, randomized (Study 1), or single-arm clinical trials (Study 2 and Study 3). Prior to enrollment, patients received therapy consisting of induction combination chemotherapy, maximum feasible surgical resection, myeloablative consolidation chemotherapy followed by autologous stem cell transplant, and radiation therapy to residual soft tissue disease.

Patients received Unituxin in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA). A total of 106 randomized patients received RA alone (RA group). Approximately 71% of patients in the Unituxin/RA group and 77% of patients in the RA group completed planned treatment.

The most common reason for premature discontinuation of study therapy was adverse reactions in the Unituxin/RA group (19%) and progressive disease (17%) in the RA group. The most common adverse drug reactions (≥25%) in the Unituxin/RA group were pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia. The most common serious adverse reactions (≥5%) in the Unituxin/RA group were infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome.

The reported adverse event profile of Unituxin in Study 2 was similar to that observed in Study 1. Study 3 was a multicenter, single-arm safety study of Unituxin in combination with GM-CSF, IL-2, and RA. In Study 3, adverse events of all CTCAE grades and laboratory data were systematically and comprehensively collected.

Of 104 patients enrolled and treated in Study 3, 77% of patients completed study therapy. In general, the adverse reaction profile of Unituxin observed in Study 3 was similar to that observed in Study 1 and Study 2. Table 7 provides the per-patient incidence of laboratory abnormalities in Study 3.

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. Neurotoxicity: prolonged urinary retention, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS).

Table 5: Selected Adverse Reactions Occurring in at Least 10% of Patients in the Unituxin/RA Group in Study 1
Adverse Reaction Includes adverse reactions that occurred in at least 10% of patients in the Unituxin/RA group with at least a 5% (All Grades) or 2% (Grades 3 to 5) absolute higher incidence in the Unituxin/RA group compared to the RA group., Adverse drug reactions were graded using CTCAE version 3.0.	Unituxin/RA (N=134)		RA (N=106)
	All Grades (%)	Grades 3 to 4 (%)	All Grades (%)	Grades 3 to 4 (%)
General Disorders and Administration Site Conditions
Pain Includes preferred terms abdominal pain, abdominal pain upper, arthralgia, back pain, bladder pain, bone pain, chest pain, facial pain, gingival pain, infusion related reaction, musculoskeletal chest pain, myalgia, neck pain, neuralgia, oropharyngeal pain, pain, pain in extremity, and proctalgia.	85	51	16	6
Pyrexia	72	40	27	6
Edema	17	0	0	0
Blood and Lymphatic System Disorders Based on investigator reported adverse reactions.
Thrombocytopenia	66	39	43	25
Lymphopenia	62	51	36	20
Anemia	51	34	22	16
Neutropenia	39	34	16	13
Immune System Disorders
Infusion reactions	60	25	9	1
Vascular Disorders
Hypotension	60	16	3	0
Capillary leak syndrome One Grade 5 adverse reaction.	40	23	1	0
Hemorrhage Includes preferred terms gastrointestinal hemorrhage, hematochezia, rectal hemorrhage, hematemesis, upper gastrointestinal hemorrhage, hematuria, hemorrhage urinary tract, renal hemorrhage, epistaxis, respiratory tract hemorrhage, disseminated intravascular coagulation, catheter site hemorrhage, hemorrhage, and hematoma.	17	6	6	3
Hypertension	14	2	7	1
Metabolism and Nutrition Disorders
Hyponatremia	58	23	12	4
Hypokalemia	43	37	4	2
Hypoalbuminemia	33	7	3	0
Hypocalcemia	27	7	0	0
Hypophosphatemia	20	8	3	0
Hyperglycemia	18	6	4	1
Hypertriglyceridemia	16	1	11	1
Decreased appetite	15	10	5	4
Hypomagnesemia	12	2	1	0
Investigations
Increased alanine aminotransferase	56	23	31	3
Increased aspartate aminotransferase	28	10	7	0
Increased serum creatinine	15	2	6	0
Increased weight	10	0	0	0
Gastrointestinal Disorders
Vomiting	46	6	19	3
Diarrhea	43	13	15	1
Nausea	10	2	3	1
Skin and Subcutaneous Tissue Disorders
Urticaria	37	13	3	0
Respiratory, Thoracic and Mediastinal Disorders
Hypoxia	24	12	2	1
Cardiac Disorders
Tachycardia Includes preferred terms tachycardia and sinus tachycardia.	19	2	1	0
Infections and Infestations
Sepsis	18	16	9	9
Device related infection	16	16	11	11
Renal and Urinary Disorders
Proteinuria	16	0	3	1
Nervous System Disorders
Peripheral neuropathy	13	3	6	0

Table 6: Comparison of Adverse Events by Treatment Cycle in the Unituxin/RA Group in Study 1
Preferred Term Includes preferred terms with a per-patient incidence of at least 20% in the Unituxin and RA group for either IL-2 or GM-CSF containing cycles., Adverse drug reactions were graded using CTCAE version 3.0.	All Grades		Severe
	GM-CSF N=134 (%)	IL-2 Seven patients who received GM-CSF in Cycle 1 discontinued prior to starting Cycle 2. N=127 (%)	GM-CSF N=134 (%)	IL-2 N=127 (%)
GM-CSF, granulocyte-macrophage colony-stimulating factor; IL-2, interleukin-2; RA, 13-cis-retinoic acid
General Disorders and administration site conditions
Pyrexia	55	65	10	37
Pain Includes preferred terms abdominal pain, abdominal pain upper, arthralgia, back pain, bladder pain, bone pain, chest pain, facial pain, gingival pain, infusion related reaction, musculoskeletal chest pain, myalgia, neck pain, neuralgia, oropharyngeal pain, pain, pain in extremity, and proctalgia.	77	61	43	35
Blood and Lymphatic System Disorders Based on investigator-reported adverse reactions.
Thrombocytopenia	62	61	31	33
Lymphopenia	54	61	33	50
Anemia	42	42	21	24
Neutropenia	25	32	19	28
Immune System Disorders
Infusion reactions	47	54	10	20
Vascular Disorders
Hypotension	43	54	5	16
Capillary leak syndrome	22	36	11	20
Metabolism and Nutrition Disorders
Hyponatremia	36	55	5	21
Hypokalemia	26	39	13	33
Hypoalbuminemia	29	29	3	5
Hypocalcemia	20	21	2	6
Investigations
Increased alanine aminotransferase	43	48	15	13
Aspartate aminotransferase increased	16	21	4	7
Gastrointestinal Disorders
Diarrhea	31	37	6	13
Vomiting	33	35	3	2
Skin and Subcutaneous Tissue Disorders
Urticaria	25	29	7	7

Table 7: Per-patient Incidence of Selected (≥5% Grade 3 to 4) Laboratory Abnormalities in Study 3
Laboratory Test Laboratory abnormalities with a per-patient incidence of at least 20% (all grades) and at least a 5% per-patient incidence of severe (Grade 3 or 4) laboratory abnormalities.	Grade Based on CTCAE version 4.0.
	All Grades %	Grades 3 to 4 %
ND, not determined
Hematology
Anemia	100	46
Neutropenia	99	63
Thrombocytopenia	98	49
Chemistry
Hypoalbuminemia	100	8
Hypocalcemia	97	7
Hyponatremia	93	36
Hyperglycemia	87	6
Aspartate Aminotransferase Increased	84	8
Alanine Aminotransferase Increased	83	13
Hypokalemia	82	41
Hypophosphatemia	78	6
Urinalysis Urinalysis results were reported as positive or negative without assessment of grade.
Urine protein	66	ND
Red blood cell casts	38	ND

Warnings & Cautions for Unituxin

Serious Infusion Reactions

Serious infusion reactions requiring urgent intervention, including blood pressure support, bronchodilator therapy, corticosteroids, infusion rate reduction, infusion interruption, or permanent discontinuation of Unituxin, included facial and upper airway edema, dyspnea, bronchospasm, stridor, urticaria, and hypotension. Infusion reactions generally occurred during or within 24 hours of completing the Unituxin infusion. Due to overlapping signs and symptoms, it was not possible to distinguish between infusion reactions and hypersensitivity reactions in some cases.

Severe urticaria occurred in 17 (13%) patients in the Unituxin/RA group but did not occur in the RA group. Serious adverse reactions consistent with anaphylaxis and resulting in permanent discontinuation of Unituxin occurred in 2 (1%) patients in the Unituxin/RA group. Prior to each Unituxin dose, administer required intravenous hydration and premedication with antihistamines, analgesics, and antipyretics.

Monitor patients closely for signs and symptoms of infusion reactions during and for at least 4 hours following completion of each Unituxin infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. For mild to moderate infusion reactions, such as transient rash, fever, rigors, and localized urticaria, that respond promptly to antihistamines or antipyretics, decrease the Unituxin infusion rate and monitor closely. Immediately interrupt or permanently discontinue Unituxin and institute supportive management for severe or prolonged infusion reactions.

Permanently discontinue Unituxin and institute supportive management for life-threatening infusion reactions.

Neurotoxicity Pain In Study 1, 114 (85%) patients treated in the Unituxin/RA group experienced pain despite pre-treatment with analgesics, including morphine sulfate infusion. Pain typically occurred during the Unituxin infusion and was most commonly reported as abdominal pain, generalized pain, extremity pain, back pain, neuralgia, musculoskeletal chest pain, and arthralgia. Premedicate with analgesics, including intravenous opioids, prior to each dose of Unituxin and continue analgesics until 2 hours following completion of Unituxin.

For severe pain, decrease the Unituxin infusion rate to 0.875 mg/m 2 /hour. Discontinue Unituxin if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures. No patients treated with RA alone experienced severe peripheral neuropathy.

The duration and reversibility of peripheral neuropathy occurring in Study 1 was not documented. In Study 3, no patients experienced peripheral motor neuropathy. Among the 9 (9%) patients who experienced peripheral sensory neuropathy of any severity, the median (min, max) duration of peripheral sensory neuropathy was 9 days.

In a study of a related anti-GD2 antibody conducted in 12 adult patients with metastatic melanoma, 2 (13%) patients developed severe motor neuropathy. One patient developed lower extremity weakness and inability to ambulate that persisted for approximately 6 weeks. Another patient developed severe lower extremity weakness resulting in an inability to ambulate without assistance that lasted for approximately 16 weeks and neurogenic bladder that lasted for approximately 3 weeks.

Complete resolution of motor neuropathy was not documented in this case. Permanently discontinue Unituxin in patients with peripheral motor neuropathy of Grade 2 or greater severity, Grade 3 sensory neuropathy that interferes with daily activities for more than 2 weeks, or Grade 4 sensory neuropathy. Neurological Disorders of the Eye Neurological disorders of the eye experienced by 2 or more patients treated with Unituxin in Studies 1, 2, or 3 included blurred vision, photophobia, mydriasis, fixed or unequal pupils, optic nerve disorder, eyelid ptosis, and papilledema.

In Study 1, 3 (2%) patients in the Unituxin/RA group experienced blurred vision, compared to no patients in the RA group. Diplopia, mydriasis, and unequal pupillary size occurred in 1 patient each in the Unituxin/RA group, compared to no patients in the RA group. The duration of eye disorders occurring in Study 1 was not documented.

Among the cases with documented resolution, the median duration of eye disorders was 4 days (range: 0, 221 days). Interrupt Unituxin in patients experiencing dilated pupil with sluggish light reflex or other visual disturbances that do not cause visual loss. Upon resolution and if continued treatment with Unituxin is warranted, decrease the Unituxin dose by 50%.

Permanently discontinue Unituxin in patients with recurrent signs or symptoms of an eye disorder following dose reduction and in patients who experience loss of vision. Prolonged Urinary Retention Urinary retention that persists for weeks to months following discontinuation of opioids has occurred in patients treated with Unituxin. Permanently discontinue Unituxin in patients with urinary retention that does not resolve following discontinuation of opioids.

Transverse Myelitis Transverse myelitis has occurred in patients treated with Unituxin. Promptly evaluate any patient with signs or symptoms of transverse myelitis, such as weakness, paresthesia, sensory loss, or incontinence. Permanently discontinue Unituxin in patients who develop transverse myelitis.

Reversible Posterior Leukoencephalopathy Syndrome Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has occurred in patients treated with Unituxin. Institute appropriate medical treatment and permanently discontinue Unituxin in patients with signs and symptoms of RPLS (eg, severe headache, hypertension, visual changes, lethargy, or seizures).

Capillary Leak Syndrome In Study 1, severe (Grade 3 to 5) capillary leak syndrome occurred in 31 (23%) patients in the Unituxin/RA group and in no patients treated with RA alone. Additionally, capillary leak syndrome was reported as a serious adverse reaction in 9 (6%) patients in the Unituxin/RA group and in no patients treated with RA alone. Prior to each Unituxin infusion, administer required intravenous hydration.

Closely monitor blood pressure during Unituxin treatment. Monitor peripheral blood counts closely during therapy with Unituxin.

Electrolyte Abnormalities In Study 1, electrolyte abnormalities occurring in at least 25% of patients who received Unituxin/RA included hyponatremia, hypokalemia, and hypocalcemia. Monitor serum electrolytes daily during therapy with Unituxin.

Atypical Hemolytic Uremic Syndrome

Hemolytic uremic syndrome in the absence of documented infection and resulting in renal insufficiency, electrolyte abnormalities, anemia, and hypertension occurred in 2 patients enrolled in Study 2 following receipt of the first cycle of Unituxin. Atypical hemolytic uremic syndrome recurred following rechallenge with Unituxin in 1 patient. Permanently discontinue Unituxin and institute supportive management for signs of hemolytic uremic syndrome.

Embryo-Fetal Toxicity Based on its mechanism of action, Unituxin may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment, and for 2 months after the last dose of Unituxin.

Drug Interactions with Unituxin

No drug-drug interaction studies have been conducted with dinutuximab.

Pregnancy Safety for Unituxin

Pregnancy Risk Summary Based on its mechanism of action, Unituxin may cause fetal harm when administered to a pregnant woman. There are no studies in pregnant women and no reproductive studies in animals to inform the drug-associated risk. Monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.

Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Pediatric Use of Unituxin

Prior to enrollment, patients achieved at least a partial response to prior first-line therapy for high-risk neuroblastoma consisting of induction combination chemotherapy, maximum feasible surgical resection, myeloablative consolidation chemotherapy followed by autologous stem cell transplant, and received radiation therapy to residual soft tissue disease. Patients randomized to the Unituxin/13-cis-retinoic acid (RA) arm (Unituxin/RA) received up to 5 cycles of Unituxin in combination with alternating cycles of granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2) plus RA, followed by 1 cycle of RA alone. Patients randomized to the RA arm received up to 6 cycles of RA monotherapy.

Study 1 demonstrated an improvement in event-free survival (EFS) and overall survival (OS) in patients in the Unituxin/RA arm compared to those in the RA arm. Monkeys also received morphine during infusion for pain management. At the high dose of 10 mg/kg (approximately equal to the 17.5 mg/m 2 clinical dose), mild degeneration of nerve fibers in the brain (medulla oblongata) and moderate degeneration of nerve fibers in the spinal cord (cervical, thoracic, and lumbar) were present.

Mild neuronal and nerve fiber degeneration were also present in the dorsal root ganglia (cervical, thoracic, and lumbar). Nerve fiber degeneration in the spinal cord and neuronal degeneration in dorsal root ganglia persisted 6 months after the end of dosing, though at lower severity. At the 10 mg/kg dose level, nerve conduction velocity (NCV) analysis showed motor and sensory NCV decreases of less than 10% compared to vehicle controls, starting on Day 27 and continuing to Day 83.

Sensory NCV decreases were still present at the end of the dosing period but were on a trend towards recovery 6 months after the end of dosing.

Contraindications for Unituxin

Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab. History of anaphylaxis to dinutuximab.

Clinical Studies of Unituxin

The safety and effectiveness of Unituxin was evaluated in a randomized, open-label, multicenter trial conducted in pediatric patients with high-risk neuroblastoma (Study 1). All patients had received prior therapy consisting of induction combination chemotherapy, maximum feasible surgical resection, myeloablative consolidation chemotherapy followed by autologous stem cell transplant, and radiation therapy to residual soft tissue disease. Patients were randomized between Day 50 and Day 77 post-autologous stem cell transplantation.

Patients were required to have achieved at least a partial response prior to autologous stem cell transplantation, have no evidence of disease progression following completion of front-line multi-modality therapy, have adequate pulmonary function (no dyspnea at rest and peripheral arterial oxygen saturation of at least 94% on room air), adequate hepatic function (total bilirubin <1.5× the upper limit of normal and ALT <5× the upper limit of normal), adequate cardiac function (shortening fraction of >30% by echocardiogram, or if shortening fraction abnormal, ejection fraction of 55% by gated radionuclide study), and adequate renal function (glomerular filtration rate at least 70 mL/min/1.73 m 2 ). Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were not eligible for enrollment. Patients randomized to the Unituxin/RA arm received up to 5 cycles of Unituxin (clinical trials material) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) (Table 8) or interleukin-2 (IL-2) (Table 9) plus 13-cis-retinoic acid (RA), followed by 1 cycle of RA alone.

In general, demographic and baseline tumor characteristics were similar across study arms. The majority (80%) of patients had International Neuroblastoma Staging System Stage 4 disease. Thirty-five percent of patients had a complete response, 43% had a very good partial response, and 23% had a partial response to therapy received prior to autologous stem cell transplant.

Forty-six percent of patients had neuroblastoma that was not MYCN-amplified, 36% had tumors with known MYCN-amplification, and MYCN status was unknown or missing in 19% of patients. Forty-three percent of patients had hyperdiploid tumors, 36% had diploid tumors, and DNA ploidy status was unknown or missing in 21% of patients. The major efficacy outcome measure was investigator-assessed event-free survival (EFS), defined as the time from randomization to the first occurrence of relapse, progressive disease, secondary malignancy, or death.

Overall survival (OS) was also evaluated. After observing a numerical improvement in EFS based on the seventh interim analysis, the Data Monitoring Committee recommended termination of accrual. Efficacy results are shown in Table is shown in Figure 1.

Figure 1: Kaplan-Meier Curve of Event-Free Survival Figure 1

Table 10: Efficacy Results
Efficacy Parameter		Unituxin/RA arm n=113	RA arm n=113
NR, not reached
EFS	No. of Events (%)	33 (29%)	50 (44%)
	Median (95% CI) (years)	NR (3.4, NR)	1.9 (1.3, NR)
	Hazard Ratio (95% CI)	0.57 (0.37, 0.89)
	p-value (log-rank test) Compared to the allocated alpha of 0.01 pre-specified for the seventh interim analysis of EFS	0.01
OS Based on an additional 3 years of follow up after the seventh interim analysis of EFS	No. of Events (%)	31 (27%)	48 (42%)
	Median (95% CI) (years)	NR (7.5, NR)	NR (3.9, NR)
	Hazard Ratio (95% CI)	0.58 (0.37, 0.91)

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

Ready to save on Unituxin?

Compare prescription prices at over 70,000 pharmacies and start saving today—no enrollment required.

Compare Unituxin Prices