Tagraxofusp, a CD123-directed fusion protein consisting of recombinant human interleukin-3 (IL-3) linked to truncated diphtheria toxin, is an antineoplastic agent.1, 10, 11
Blastic Plasmacytoid Dendritic Cell Neoplasm
Tagraxofusp-erzs is used for the treatment of blastic plasmacytoid dendritic cell neoplasm;1, 2 the drug has been designated an orphan drug by FDA for the treatment of this cancer.3 The current indication for tagraxofusp-erzs is based on rate of complete response (CR) or clinical complete response (CRc) in patients with previously untreated blastic plasmacytoid dendritic cell neoplasm.1
The current indication for tagraxofusp-erzs in the treatment of blastic plasmacytoid dendritic cell neoplasm is based principally on the results of a cohort of 13 patients with previously untreated blastic plasmacytoid dendritic cell neoplasm in an open-label, multicenter, single-arm phase 2 study (Study 0114).1, 2, 9 In this study, patients received tagraxofusp-erzs 12 mcg/kg administered by IV infusion over 15 minutes once daily on days 1-5 of each 21-day cycle.1, 2 The primary measure of efficacy was rate of CR or CRc; an additional outcome measure was duration of response.2 CR was defined as absence of disease at each site of initial disease,2 and CRc was defined as CR with the presence of residual skin abnormalities not indicative of active disease.1
At a median follow-up of 11.5 months in the previously untreated cohort, CR or CRc was achieved in 53.8% of patients with a median time to response of 57 days (range: 14-107 days).1 At the time of analysis, the median duration of response had not been reached.1 In a cohort of 15 patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm, CR or CRc was achieved in 2 patients; the duration of CR or CRc was 111 or 424 days, respectively.1
Vital signs and laboratory parameters (i.e., serum albumin, aminotransferase, and creatinine concentrations) should be assessed prior to preparation of each dose of tagraxofusp and as clinically indicated during therapy.1 Monitoring should be performed in an inpatient setting during cycle 1, including at least 24 hours following the last dose of the cycle.1, 5 Subsequent cycles should be administered in a setting where adequate monitoring for patients with hematologic malignancies can be performed for at least 4 hours following each dose.1
Because of the risk of hypersensitivity reactions associated with tagraxofusp, a premedication regimen consisting of an antihistamine (e.g., diphenhydramine hydrochloride), H2-receptor antagonist, systemic corticosteroid (e.g., IV methylprednisolone 50 mg [or equivalent]), and acetaminophen should be administered approximately 60 minutes prior to each tagraxofusp infusion.1 (See Hypersensitivity Reactions under Warnings/Precautions: Sensitivity Reactions, in Cautions.)
Because of the risk of capillary leak syndrome associated with tagraxofusp, adequate cardiac function should be confirmed prior to initiating tagraxofusp therapy.1 The initial dose of the drug should be delayed until serum albumin concentrations are at least 3.2 g/dL.1 (See Capillary Leak Syndrome under Warnings/Precautions: Warnings, in Cautions.)
Tagraxofusp-erzs is available only from designated specialty distributors.4 The manufacturer should be contacted for additional information.4
Tagraxofusp-erzs is administered by IV infusion over 15 minutes using a controlled-infusion device (i.e., syringe pump).1 To ensure complete administration of tagraxofusp-erzs, the infusion set should be flushed with at least 3 mL of 0.9% sodium chloride injection over 15 minutes using a syringe pump.1
Unopened vials of tagraxofusp-erzs injection concentrate should be stored at -25 to -15°C and retained in the original carton for protection from light.1
Tagraxofusp-erzs injection concentrate must be diluted prior to IV administration.1 Prior to dilution, frozen tagraxofusp-erzs injection concentrate must be completely thawed at room temperature (15-25°C) for 15-30 minutes in the original carton; heat sources other than ambient air temperature should not be used.1 Once thawed, the injection concentrate may be stored at room temperature for approximately 1 hour prior to dilution; the injection concentrate should not be refrozen.1 Tagraxofusp-erzs injection concentrate and diluted solutions of the drug should be inspected visually for particulate matter and discoloration prior to dilution and administration.1 Thawed tagraxofusp-erzs injection concentrate should be clear and colorless; the solution may contain a few white to translucent particulates.1
Based on the indicated dose of tagraxofusp-erzs, the appropriate number of vials of the drug should be thawed and diluted.1 Prior to dilution of the injection concentrate, vial(s) labeled as containing 1000 mcg/mL of tagraxofusp-erzs should be gently swirled.1 Tagraxofusp-erzs injection concentrate is diluted by adding 9 mL of 0.9% sodium chloride injection followed by 1 mL of tagraxofusp-erzs injection concentrate (containing 1000 mcg/mL) into an empty sterile 10-mL vial to achieve a final concentration of 100 mcg/mL.1 The diluted solution for infusion should be gently inverted at least 3 times and should not be shaken.1 An appropriate dose of diluted tagraxofusp-erzs solution should be withdrawn from the vial into a new sterile syringe affixed with a product label.1 A 0.9% sodium chloride flush label should be affixed to a separate syringe containing at least 3 mL of 0.9% sodium chloride injection.1
The manufacturer's labeling should be consulted for detailed information on infusion system requirements (e.g., components, set-up) and procedures for IV infusion of tagraxofusp-erzs.1
The diluted solution may be infused immediately or stored at room temperature and used within 4 hours of completing dose preparation.1, 6 Any partially used vials should be discarded.1
Blastic Plasmacytoid Dendritic Cell Neoplasm
For the treatment of blastic plasmacytoid dendritic cell neoplasm in adults and pediatric patients 2 years of age or older, the recommended dosage of tagraxofusp-erzs is 12 mcg/kg administered as a 15-minute IV infusion on days 1-5 of each 21-day cycle.1
Therapy should be continued until disease progression or unacceptable toxicity occurs.1
Therapy Interruption for Toxicity
If toxicities requiring temporary interruption of therapy occur, the dosing period for tagraxofusp should not extend beyond day 10 of the cycle.1
If serum albumin concentration less than 3.5 g/dL or an absolute reduction of 0.5 g/dL or greater from the precycle value (value prior to initiation of current cycle) occurs, symptomatic treatment of capillary leak syndrome should be initiated.1 (See Capillary Leak Syndrome under Warnings/Precautions: Warnings, in Cautions.)
For serum aminotransferase (ALT and/or AST) concentrations exceeding 5 times the upper limit of normal (ULN), tagraxofusp therapy should be interrupted until ALT and AST concentrations return to baseline values or decrease to no more than 2.5 times the ULN.1
For serum creatinine concentrations exceeding 1.8 mg/dL, tagraxofusp therapy should be interrupted until serum creatinine concentrations improve to 1.8 mg/dL or less.1
For creatinine clearance less than 60 mL/minute, tagraxofusp therapy should be interrupted until creatinine clearance improves to 60 mL/minute or greater.1
If vital sign abnormalities occur, interruption of tagraxofusp therapy may be necessary, as shown in the Recommended Therapy Interruption for Vital Sign Abnormalities table (see Table 1).1
Vital Sign | Dosage Modification |
|---|---|
Weight increase of ≥1.5 kg from predose weight on the previous treatment day | Follow recommendations for management of capillary leak syndrome (see Capillary Leak Syndrome under Warnings/Precautions: Warnings, in Cautions) |
Systolic blood pressure (SBP) ≥160 mm Hg | Interrupt therapy until SBP is <160 mm Hg |
SBP ≤80 mm Hg | Interrupt therapy until SBP is >80 mm Hg |
Heart rate ≥130 beats per minute | Interrupt therapy until heart rate is <130 beats per minute |
Heart rate ≤40 beats per minute | Interrupt therapy until heart rate is >40 beats per minute |
Body temperature ≥38°C | Interrupt therapy until body temperature is <38°C |
Tagraxofusp therapy should be withheld and symptomatic treatment should be initiated if any of the following occur: serum albumin concentration decreases to less than 3.5 g/dL or the absolute reduction in serum albumin concentration is 0.5 g/dL or more from the precycle value (value prior to initiation of current cycle); weight increases by 1.5 kg or more from the predose weight on the previous treatment day; or edema, fluid overload, and/or hypotension occurs.1 (See Capillary Leak Syndrome under Warnings/Precautions: Warnings, in Cautions.) If the toxicity resolves and treatment for hemodynamic instability was not required, tagraxofusp therapy may be resumed during the same cycle.1 If the toxicity does not resolve or treatment for hemodynamic instability was required (e.g., IV fluids, vasopressor therapy), tagraxofusp therapy should be withheld for the remainder of the current cycle, even if signs or symptoms resolve following treatment for hemodynamic instability; if all signs or symptoms of capillary leak syndrome resolve, tagraxofusp-erzs may be resumed in the next cycle in hemodynamically stable patients.1
If mild or moderate hypersensitivity reactions occur, the tagraxofusp infusion should be interrupted and supportive treatment should be initiated as necessary; upon resolution of symptoms, the infusion may be resumed at the same rate.1 (See Hypersensitivity Reactions under Warnings/Precautions: Sensitivity Reactions, in Cautions.)
If severe hypersensitivity reactions occur, tagraxofusp therapy should be permanently discontinued and supportive treatment should be initiated as necessary.1
The manufacturer makes no specific dosage recommendations for patients with renal or hepatic impairment or geriatric patients.1 (See Specific Populations under Cautions: Warnings/Precautions.)
The manufacturer states that there are no known contraindications to the use of tagraxofusp-erzs.1
Capillary leak syndrome, sometimes life-threatening or fatal, has been reported in patients receiving tagraxofusp-erzs.1 In clinical trials, capillary leak syndrome occurred in 55% of patients receiving tagraxofusp-erzs; grade 1-2, 3, or 4 capillary leak syndrome occurred in 46, 6, or 1%, respectively, of patients receiving the drug.1 Capillary leak syndrome resulted in death in 2% of patients receiving tagraxofusp-erzs.1 Common signs and symptoms of capillary leak syndrome include hypoalbuminemia, edema, weight gain, and hypotension.1
Vital signs (i.e., blood pressure, heart rate, body temperature, weight) and serum albumin concentrations should be assessed prior to each tagraxofusp-erzs dose and as clinically indicated during therapy.1 Prior to initiation of tagraxofusp therapy, adequate cardiac function should be confirmed.1 The initial dose of the drug should be delayed until serum albumin concentrations are at least 3.2 g/dL.1 Patients should be monitored for manifestations of capillary leak syndrome (e.g., weight gain, new-onset or worsening edema, pulmonary edema, hypotension) during therapy.1
Capillary leak syndrome may be life-threatening or fatal if not treated appropriately.1 Patients who develop signs or symptoms of capillary leak syndrome should receive symptomatic treatment (i.e., albumin replacement therapy, IV fluids, vasopressors, systemic corticosteroids, diuretics) as described in the Recommended Symptomatic Treatment for Capillary Leak Syndrome table (see Table 2) until the toxicity resolves.1 Temporary interruption of tagraxofusp therapy may be necessary depending on the severity of the sign or symptom.1 (See Capillary Leak Syndrome under Dosage: Therapy Interruption for Toxicity, in Dosage and Administration.)
Manifestation | Symptomatic Treatment |
|---|---|
Serum albumin <3.5 g/dL or an absolute reduction of ≥0.5 g/dL from the precycle value (value prior to initiation of current cycle) | Administer albumin 25 g IV every 12 hours or more frequently until serum albumin concentration reaches ≥3.5 g/dL and absolute difference from precycle value is ≤0.5 g/dL |
Weight increase of ≥1.5 kg from predose weight on the previous treatment day | Administer albumin 25 g IV every 12 hours or more frequently and manage hemodynamic status (e.g., diuretic therapy if normotensive or hypertensive; IV fluids and vasopressor therapy if hypotensive) as clinically indicated |
Continue symptomatic treatment until body weight is <1.5 kg above predose weight on previous day | |
Edema, fluid overload, and/or hypotension | Administer albumin 25 g IV every 12 hours or more frequently until serum albumin concentration reaches ≥3.5 g/dL Administer systemic corticosteroid therapy (e.g., 1 mg/kg of methylprednisolone daily [or equivalent]) as clinically necessary or until manifestations of capillary leak syndrome resolve Intensively manage hemodynamic status (e.g., IV fluids, diuretic therapy) and hypotension, if present, as clinically necessary or until manifestations of capillary leak syndrome resolve |
Severe hypersensitivity reactions (e.g., rash, pruritus, stomatitis, wheezing) have been reported in patients receiving tagraxofusp-erzs.1 In clinical trials, hypersensitivity reactions occurred in 46% of patients receiving tagraxofusp-erzs; grade 3 or greater hypersensitivity reactions occurred in 10% of patients receiving the drug.1
Patients receiving tagraxofusp should receive premedication with an antihistamine, H2-receptor antagonist, systemic corticosteroid, and acetaminophen prior to each tagraxofusp infusion.1 (See Dosage and Administration: General.) Patients should be monitored for manifestations of hypersensitivity reactions during each tagraxofusp infusion.1 If hypersensitivity reactions occur, temporary interruption or permanent discontinuance of tagraxofusp may be required and supportive care should be provided.1 (See Hypersensitivity Reactions under Dosage: Therapy Interruption for Toxicity, in Dosage and Administration.)
Other Warnings and Precautions
Elevations in aminotransferase (ALT or AST) concentrations occur frequently in patients receiving tagraxofusp.1 In clinical trials, elevations in aminotransferase concentrations occurred in 88% of patients receiving tagraxofusp-erzs; grade 1-2, 3, or 4 elevations in aminotransferase concentrations occurred in 48, 36, or 4%, respectively, of patients receiving the drug.1
Serum ALT and AST concentrations should be evaluated prior to each dose of tagraxofusp.1 If ALT and/or AST elevations exceed 5 times the upper limit of normal (ULN), tagraxofusp therapy should be interrupted.1 Therapy with the drug should be reinitiated after serum ALT and AST concentrations have returned to baseline values or decreased to no more than to 2.5 times the ULN.1
There is potential for immunogenicity with tagraxofusp therapy.1 Because of the high rate of primary and booster immunizations against diphtheria, preexisting anti-tagraxofusp antibodies were detected in 115 of 120 patients (96%); neutralizing antibodies to tagraxofusp were detected in 18 of 91 patients (21%) who tested positive for antibody formation at baseline.1, 7 Anti-tagraxofusp antibody formation was detected in 107 of 108 patients (99%) receiving tagraxofusp-erzs at the recommended dosa 1, 7 antibody titers increased by the end of cycle 2 in most patients.1 Neutralizing antibodies to tagraxofusp were detected in 86 of 101 patients (85%) who tested positive for antibody formation.1, 7 Anti-interleukin-3 antibody formation was detected in 73 of 108 patients (68%) receiving tagraxofusp-erzs; anti-interleukin-3 antibody formation occurred by cycle 3 in most patients.1, 7
Following IV administration of tagraxofusp-erzs, area under the concentration-time curve (AUC) and peak plasma concentration were reduced by 34.6 or 50.6%, respectively, and clearance of the drug was increased by 1.96-fold in patients with preexisting anti-tagraxofusp antibodies compared with patients without anti-tagraxofusp antibodies at baseline.1, 7 Because of the life-threatening nature of blastic plasmacytoid dendritic cell neoplasm and high rate of primary and booster immunizations against diphtheria in the population, no dosage adjustment is necessary in patients with preexisting anti-tagraxofusp antibodies.7
Tagraxofusp may cause fetal harm if administered to pregnant women based on its mechanism of action.1
Pregnancy should be avoided during tagraxofusp therapy.1 The manufacturer states that a pregnancy test should be performed within 7 days prior to initiation of tagraxofusp therapy in females of reproductive potential and that such females should be advised to use effective contraceptive methods while receiving tagraxofusp and for at least 1 week after the last dose.1 If tagraxofusp is used during pregnancy, the patient should be apprised of the potential fetal hazard.1
It is not known whether tagraxofusp distributes into milk in humans or whether the drug has any effects on nursing infants or on milk production.1, 8 Because of the potential for serious adverse reactions to tagraxofusp in nursing infants, women should be advised to discontinue nursing during tagraxofusp therapy and for 1 week after the last dose.1, 8
Safety and efficacy of tagraxofusp have not been established in pediatric patients younger than 2 years of age.1
Safety and efficacy of tagraxofusp for the treatment of blastic plasmacytoid dendritic cell neoplasm in pediatric patients are supported by extrapolation of data from the principal efficacy study (STML-401-0114) evaluating tagraxofusp-erzs in adults.1 Limited data in 3 pediatric patients (range: 2 years to less than 17 years of age) receiving tagraxofusp-erzs at the recommended dosage indicate that adverse effects in pediatric patients are similar to those reported in adults.1
In the STML-401-0114 study evaluating tagraxofusp-erzs in patients with blastic plasmacytoid dendritic cell neoplasm, 23% of patients receiving the recommended dosage of the drug were 75 years of age or older.1 Adverse CNS effects (i.e., confusion, delirium, mental status changes, dementia, encephalopathy) occurred more frequently in geriatric patients.1
Population pharmacokinetic analysis suggests that age (range: 22-84 years) has no effect on the pharmacokinetics of tagraxofusp.1, 7
Population pharmacokinetic analysis suggests that mild (total bilirubin concentration not exceeding the upper limit of normal [ULN] with AST concentration exceeding the ULN, or total bilirubin concentration exceeding the ULN, but not more than 1.5 times the ULN, with any AST concentration) or moderate (total bilirubin concentration exceeding 1.5 times, but not more than 3 times, the ULN with any AST concentration) hepatic impairment has no effect on the pharmacokinetics of tagraxofusp-erzs.1, 7 The effect of severe hepatic impairment (total bilirubin concentration exceeding 3 times the ULN with any AST concentration) on the pharmacokinetics of tagraxofusp-erzs is unknown.1
Population pharmacokinetic analysis suggests that mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-89 mL/minute per 1.73 m2) has no effect on the pharmacokinetics of tagraxofusp-erzs.1, 7 The effect of severe renal impairment (eGFR 15-29 mL/minute per 1.73 m2) on the pharmacokinetics of tagraxofusp-erzs is unknown.1
Adverse effects reported in 30% or more of patients receiving tagraxofusp-erzs include capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, and weight gain.1 Laboratory abnormalities reported in 50% or more of patients receiving tagraxofusp-erzs include decreased concentrations of albumin, decreased platelet concentrations, decreased concentrations of hemoglobin, decreased concentrations of calcium, decreased concentrations of sodium, elevated concentrations of glucose, and elevated concentrations of aminotransferases (i.e., AST, ALT).1
No formal drug interaction studies have been performed to date.1 Tagraxofusp is not expected to be metabolized by cytochrome P-450 (CYP) isoenzymes.7 The drug also is not expected to be a substrate of metabolic transporters.7
Tagraxofusp, a CD123-directed fusion protein consisting of recombinant human interleukin-3 (IL-3) linked to truncated diphtheria toxin, is an antineoplastic agent.1, 10, 11 The drug is produced by recombinant DNA technology in Escherichia coli cells.1 Tagraxofusp is a fusion protein designed to direct the cytocidal activity of diphtheria toxin to cells that express the IL-3 receptor, a cytokine overexpressed in certain hematologic malignancies (i.e., acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, acute lymphocytic leukemia, hairy cell leukemia, myeloproliferative neoplasms, blastic plasmacytoid dendritic cell neoplasm) relative to normal cells.11, 12 The IL-3 portion of tagraxofusp binds specifically to IL-3 receptor alpha-chain (IL-3R alpha; also known as CD123).11, 12 Following binding of tagraxofusp to CD123-expressing cells, the resultant complex is internalized by the cell.10, 12 Truncated and catalytic domains of the diphtheria toxin are released into cytosol and inactivate adenosine diphosphate (ADP)-ribosylation of elongation factor 2 causing inhibition of protein synthesis and subsequent apoptosis.1, 10, 12
Following administration of tagraxofusp-erzs 12 mcg/kg by IV infusion over 15 minutes, area under the concentration-time curve (AUC) and peak plasma concentration of the drug were reduced by 34.6 and 50.6%, respectively, and clearance of the drug was increased by 1.96-fold in patients with preexisting anti-tagraxofusp antibodies compared with patients without anti-tagraxofusp antibodies at baseline; however, no dosage adjustment is necessary in such patients.1, 7 The mean terminal half-life of tagraxofusp is 0.7 hours.1
Pharmacokinetics of tagraxofusp does not appear to be affected by age (range: 22-84 years), sex, or body weight.1, 7
Risk of capillary leak syndrome.1 Importance of informing clinician if manifestations of capillary leak syndrome (e.g., new or worsening edema, weight gain, shortness of breath, hypotension) occur after infusion of tagraxofusp.1
Risk of hypersensitivity reactions.1 Importance of informing clinician if symptoms of such reactions, including rash, flushing, wheezing, and swelling of the face, occur.1
Risk of hepatotoxicity.1 Importance of informing clinician if symptoms of hepatotoxicity (e.g., fatigue, anorexia, right upper quadrant pain) occur.1
Risk of fetal harm.1 Necessity of advising females of reproductive potential that they should use an effective method of contraception while receiving the drug and for at least 1 week after the last dose.1 If pregnancy occurs, advise pregnant women of potential risk to the fetus.1
Importance of advising women to avoid breast-feeding during tagraxofusp therapy.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., renal impairment).1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Additional Information
Overview® (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity. For further information on the handling of antineoplastic agents, see the ASHP Guidelines on Handling Hazardous Drugs at [Web].
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Tagraxofusp-erzs can only be obtained through designated specialty distributors.4 (See Restricted Distribution under Dosage and Administration: General.)
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Concentrate, for injection, for IV infusion | 1000 mcg/mL (1000 mcg) | Stemline Therapeutics |
AHFS® Drug Information. © Copyright, 1959-2026, Selected Revisions September 21, 2020. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
1. Stemline Therapeutics, Inc. Elzonris® (tagraxofusp-erzs) injection for intravenous use prescribing information. New York, NY; 2018 Dec.
2. Pemmaraju N, Lane AA, Sweet KL et al. Tagraxofusp in Blastic Plasmacytoid Dendritic-Cell Neoplasm. N Engl J Med . 2019; 380:1628-1637. [PubMed 31018069]
3. Food and Drug Administration. Search orphan drug designations and approvals. From FDA website. Accessed 2019 Nov 27. [Web]
4. Stemline Therapeutics, Inc. Access, reimbursement support, care: Stemline ARCTM Access. From Elzonris® for Healthcare Professionals website. Accessed 2019 Nov 27. [Web]
5. Stemline Therapeutics, Inc. Dosing: Administration. From Elzonris® for Healthcare Professionals website. Accessed 2019 Dec 2. [Web]
6. Stemline Therapeutics, Inc. Elzonris® (tagraxofusp-erzs) dose administration instructions. From Elzonris® for Healthcare Professionals website. Accessed 2019 Dec 5. [Web]
7. Food and Drug Administration. Center for Drug Evaluation and Research. Application number: 761116Orig1s000: Clinical pharmacology and biopharmaceutics review(s). From FDA website. [Web]
8. Drugs and Lactation Database (LactMed). Tagraxofusp. From US National Library of Medicine website. Accessed 2019 Sept 18. [Web]
9. Food and Drug Administration. Center for Drug Evaluation and Research. Application number: 761116Orig1s000: Clinical review(s). From FDA website. [Web]
10. Frankel AE, Woo JH, Ahn C et al. Activity of SL-401, a targeted therapy directed to interleukin-3 receptor, in blastic plasmacytoid dendritic cell neoplasm patients. Blood . 2014; 124:385-92. [PubMed 24859366]
11. Economides MP, McCue D, Lane AA et al. Tagraxofusp, the first CD123-targeted therapy and first targeted treatment for blastic plasmacytoid dendritic cell neoplasm. Expert Rev Clin Pharmacol . 2019; 12:941-946. [PubMed 31465247]
12. Syed YY. Tagraxofusp: First Global Approval. Drugs . 2019; 79:579-583. [PubMed 30859413]
13. Alkharabsheh O, Frankel AE. Clinical Activity and Tolerability of SL-401 (Tagraxofusp): Recombinant Diphtheria Toxin and Interleukin-3 in Hematologic Malignancies. Biomedicines . 2019; 7 [PubMed 30621282]