ELZONRIS (Tagraxofusp-erzs)
CD123-directed cytotoxin for blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Quick Facts About ELZONRIS
Key Takeaways About ELZONRIS
- First approved BPDCN therapy: ELZONRIS was the first medication specifically approved by the FDA for blastic plasmacytoid dendritic cell neoplasm in both adults and children aged 2 and older
- Boxed warning for capillary leak syndrome: Patients must have serum albumin of at least 3.2 g/dL before each infusion and be closely monitored for signs of CLS
- Hospital administration required: Given as an intravenous infusion over 15 minutes, first cycle must be administered as an inpatient with 24-hour monitoring
- Significant clinical benefit: Demonstrated a complete response rate of approximately 72% in treatment-naive BPDCN patients in clinical trials
- Pre-medication is mandatory: Patients must receive H1 and H2 antagonists, corticosteroids, and acetaminophen approximately 60 minutes before each infusion
What Is ELZONRIS and What Is It Used For?
ELZONRIS (tagraxofusp-erzs) is a CD123-directed cytotoxin approved for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients aged 2 years and older. It is the first therapy specifically developed and approved for this rare, aggressive blood cancer.
ELZONRIS represents a major breakthrough in the treatment of BPDCN, a rare and highly aggressive hematologic malignancy that was previously associated with very poor outcomes. Before ELZONRIS received FDA approval in December 2018, there was no standardized treatment specifically indicated for BPDCN, and patients were typically treated with acute leukemia-type chemotherapy regimens or stem cell transplantation, often with limited success and high relapse rates.
The active substance in ELZONRIS is tagraxofusp-erzs, a recombinant protein composed of human interleukin-3 (IL-3) genetically fused to a truncated form of diphtheria toxin. This unique design allows the drug to specifically target cells expressing CD123, the interleukin-3 receptor alpha chain (IL-3Rα). CD123 is consistently and highly overexpressed on the surface of BPDCN tumor cells, making it an ideal therapeutic target. When ELZONRIS binds to CD123, it is internalized into the cell, where the diphtheria toxin catalytic domain inhibits protein synthesis through ADP-ribosylation of elongation factor 2 (EF-2), ultimately leading to cell death.
BPDCN is an extremely rare cancer, with an estimated incidence of approximately 0.44 cases per million persons per year. It predominantly affects older adults, with a median age at diagnosis of approximately 65-70 years, and shows a male-to-female ratio of roughly 3:1. The disease commonly presents with skin lesions (purplish-brown nodules or bruise-like patches), but frequently involves the bone marrow, peripheral blood, and lymph nodes. Without treatment, BPDCN progresses rapidly and is typically fatal within 12-14 months.
Mechanism of Action
The mechanism of action of ELZONRIS is elegantly targeted. The IL-3 portion of the molecule binds specifically to CD123 on the cell surface, functioning like a key fitting into a lock. Once bound, the entire drug-receptor complex is internalized into the cell through receptor-mediated endocytosis. Inside the cell, the truncated diphtheria toxin is released from the endosome into the cytoplasm, where it catalyzes the ADP-ribosylation of elongation factor 2. This irreversibly inactivates EF-2, halting all protein synthesis within the cell, which rapidly leads to apoptosis (programmed cell death).
Because CD123 is overexpressed on BPDCN cells compared to normal tissues, ELZONRIS achieves a degree of selectivity for malignant cells. However, CD123 is also expressed at lower levels on normal hematopoietic progenitor cells, monocytes, and plasmacytoid dendritic cells, which accounts for some of the hematologic toxicities observed during treatment. The half-life of tagraxofusp is approximately 42 minutes following intravenous administration, reflecting its rapid cellular uptake and intracellular processing.
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) was previously known by various names including blastic NK-cell lymphoma and CD4+/CD56+ hematodermic neoplasm. It was reclassified by the World Health Organization (WHO) in 2008 as a distinct entity under acute myeloid leukemia and related neoplasms. The disease arises from precursors of plasmacytoid dendritic cells, which normally play a key role in immune defense against viral infections.
What Should You Know Before Taking ELZONRIS?
Before starting ELZONRIS, patients must have adequate serum albumin levels (at least 3.2 g/dL), liver function tests, and complete blood counts. ELZONRIS carries a boxed warning for capillary leak syndrome (CLS), which can be fatal. Treatment should only be administered in healthcare settings with access to cardiopulmonary resuscitation equipment.
ELZONRIS is a potent targeted therapy that requires thorough medical evaluation before initiation and careful monitoring throughout treatment. Given its mechanism of action and potential for serious adverse effects, several important considerations must be addressed before starting therapy. Your healthcare team will perform comprehensive baseline assessments and discuss the risks and benefits of treatment in detail.
Contraindications
ELZONRIS is contraindicated in patients with a known severe hypersensitivity to tagraxofusp-erzs or any of its excipients, including trometamol (tromethamine), sodium chloride, and sorbitol. Patients who have experienced severe hypersensitivity reactions to diphtheria toxin-based products should not receive ELZONRIS, as the drug contains a truncated diphtheria toxin component.
Additionally, treatment should not be initiated in patients whose serum albumin level is below 3.2 g/dL, as low albumin is a significant risk factor for the development of capillary leak syndrome. If albumin falls below this threshold during treatment, the infusion must be withheld until albumin levels recover to at least 3.2 g/dL.
Warnings and Precautions
ELZONRIS can cause capillary leak syndrome (CLS), including life-threatening and fatal cases. Monitor for signs and symptoms of CLS and ensure serum albumin is at least 3.2 g/dL before each dose. Administer ELZONRIS only in a healthcare setting with access to cardiopulmonary resuscitation. Monitor serum albumin levels before and during treatment. If CLS develops, manage promptly with supportive care.
Capillary leak syndrome (CLS) is the most significant risk associated with ELZONRIS therapy. CLS occurs when fluid and proteins leak from the blood vessels into surrounding tissues, leading to hypotension, hypoalbuminemia, edema, and in severe cases, organ failure and death. In clinical trials, CLS occurred in approximately 55% of patients treated with ELZONRIS, with Grade 3 or higher CLS occurring in approximately 33% of patients. CLS-related deaths have been reported. The risk is highest during the first cycle of treatment, and patients should be hospitalized for the first cycle with monitoring for at least 24 hours after each infusion.
Hepatotoxicity is another important concern with ELZONRIS. Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been frequently observed during treatment. In clinical trials, elevated ALT occurred in approximately 84% of patients, with Grade 3 or higher elevations in approximately 42%. Liver function tests should be performed before and during each treatment cycle. If severe hepatotoxicity develops, treatment should be withheld or permanently discontinued depending on the severity and clinical context.
Hypersensitivity reactions, including anaphylaxis, have been reported with ELZONRIS. Pre-medication with H1 and H2 receptor antagonists, a corticosteroid (such as methylprednisolone or dexamethasone), and acetaminophen is required approximately 60 minutes before each infusion. Patients should be monitored for signs of hypersensitivity during and after infusion, including rash, urticaria, pruritus, flushing, dyspnea, and hypotension.
Pregnancy and Breastfeeding
Based on its mechanism of action, ELZONRIS can cause fetal harm when administered to pregnant women. The drug works by inhibiting protein synthesis, which is essential for fetal development. There are no adequate and well-controlled studies of ELZONRIS in pregnant women. Women of reproductive potential should use effective contraception during ELZONRIS treatment and for at least one week after the final dose.
It is not known whether tagraxofusp-erzs is excreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during ELZONRIS treatment and for at least one week after the final dose. The decision to discontinue breastfeeding or discontinue the drug should take into account the benefit of treatment to the mother and the potential risk to the infant.
There are no human data on the effect of ELZONRIS on fertility. Based on animal toxicology studies, ELZONRIS may impair fertility in both males and females. Patients who wish to have children in the future should discuss fertility preservation options with their healthcare provider before starting treatment.
How Does ELZONRIS Interact with Other Drugs?
No formal drug interaction studies have been conducted with ELZONRIS. However, caution is advised when combining ELZONRIS with hepatotoxic agents, live vaccines, anticoagulants, and drugs that lower albumin levels, as these may increase the risk of serious adverse effects.
While no dedicated drug-drug interaction studies have been performed with tagraxofusp-erzs, there are several clinically important considerations regarding concomitant medications. The healthcare team should carefully review all current medications before initiating ELZONRIS therapy and monitor for potential interactions throughout the treatment course. Given the drug's mechanism of action and its toxicity profile, particular attention should be paid to medications that may exacerbate hepatotoxicity, affect albumin levels, or interact with the immune system.
| Interacting Drug/Class | Type | Effect | Recommendation |
|---|---|---|---|
| Live vaccines | Major | Risk of disseminated vaccine infection due to immunosuppression | Avoid live vaccines during and after treatment until immune recovery |
| Hepatotoxic agents (e.g., methotrexate, acetaminophen in high doses, azathioprine) | Major | Additive hepatotoxicity; increased risk of severe liver injury | Monitor liver function closely; consider dose reduction or discontinuation of hepatotoxic medications |
| Anticoagulants (e.g., warfarin, heparin, DOACs) | Moderate | ELZONRIS-induced thrombocytopenia increases bleeding risk | Monitor platelet counts and adjust anticoagulant dose as needed |
| Drugs lowering albumin levels | Major | May increase risk of capillary leak syndrome | Monitor serum albumin more frequently; consider alternative agents |
| CYP450 substrates | Minor | No formal studies; protein-based drug unlikely to affect CYP enzymes | No specific dose adjustments expected; monitor as clinically indicated |
| Corticosteroids (pre-medication) | Beneficial | Required as pre-medication to reduce hypersensitivity risk | Administer approximately 60 minutes before each ELZONRIS infusion |
Major Interactions
The most clinically significant interactions involve live vaccines and hepatotoxic agents. ELZONRIS causes substantial immunosuppression through its effects on CD123-positive immune cells, including depletion of plasmacytoid dendritic cells and other hematopoietic progenitors. This immunosuppression creates a heightened risk of disseminated infection from live attenuated vaccines such as measles, mumps, rubella (MMR), varicella, oral polio, rotavirus, yellow fever, and BCG. Live vaccines should be avoided during treatment and for a sufficient period after treatment completion, as determined by the treating physician based on immune recovery.
Hepatotoxic medications should be used with extreme caution during ELZONRIS therapy. Given that approximately 84% of patients in clinical trials experienced elevated transaminases, and 42% experienced Grade 3 or higher elevations, the addition of other hepatotoxic agents significantly increases the risk of severe liver injury. When possible, hepatotoxic medications should be replaced with safer alternatives during the ELZONRIS treatment course.
Minor Interactions
Because tagraxofusp-erzs is a recombinant protein, it is not expected to be metabolized by cytochrome P450 (CYP) enzymes or interact with drugs through traditional pharmacokinetic mechanisms. However, the overall physiological changes induced by ELZONRIS treatment, including fluid shifts, changes in organ function, and hematologic effects, could theoretically alter the pharmacokinetics or pharmacodynamics of concomitant medications. Patients taking medications with a narrow therapeutic index should be monitored more closely during ELZONRIS treatment.
What Is the Correct Dosage of ELZONRIS?
The recommended dose of ELZONRIS is 12 micrograms per kilogram of body weight administered as an intravenous infusion over 15 minutes once daily on days 1 through 5 of each 21-day treatment cycle. The first cycle must be administered in an inpatient setting with at least 24 hours of monitoring after each infusion.
ELZONRIS dosing is weight-based and follows a strict treatment schedule designed to maximize efficacy while allowing for monitoring and management of adverse effects. The drug is administered exclusively by healthcare professionals in a clinical setting equipped for cardiopulmonary resuscitation. Treatment cycles continue until disease progression, unacceptable toxicity, or clinical decision to discontinue.
Adults (18 years and older)
Standard dose: 12 mcg/kg intravenously over 15 minutes, once daily on days 1-5 of each 21-day cycle
Cycle 1: Must be administered as inpatient with monitoring for at least 24 hours after each infusion
Subsequent cycles: May be administered in outpatient setting if Cycle 1 was well tolerated
Duration: Continue until disease progression or unacceptable toxicity
Pediatric Patients (2 years and older)
Standard dose: 12 mcg/kg intravenously over 15 minutes, once daily on days 1-5 of each 21-day cycle
Same dosing as adults: Weight-based dosing accounts for body size differences
Monitoring: Same inpatient monitoring requirements apply for first cycle
ELZONRIS has not been studied in children under 2 years of age.
Elderly Patients (65 years and older)
No dose adjustment: Clinical trials included patients aged 65 and older; no specific dose modification is recommended based on age alone
Consideration: Elderly patients may be more susceptible to adverse effects, particularly CLS and hepatotoxicity; closer monitoring is recommended
Renal/hepatic impairment: No formal studies in patients with renal or hepatic impairment; use clinical judgement
| Parameter | Details |
|---|---|
| Dose | 12 mcg/kg body weight |
| Route | Intravenous infusion over 15 minutes |
| Schedule | Days 1-5 of each 21-day cycle |
| Pre-medication | H1 antagonist, H2 antagonist, corticosteroid, and acetaminophen ~60 min before infusion |
| Albumin requirement | Serum albumin must be ≥ 3.2 g/dL before each dose |
| Monitoring (Cycle 1) | Inpatient with ≥ 24-hour post-infusion monitoring |
Missed Dose
If a scheduled dose of ELZONRIS is missed during a treatment cycle, the missed dose should not be made up. The remaining doses should be administered as planned within the current cycle. If more than two consecutive doses are missed within a cycle, your healthcare provider will determine whether to continue the current cycle or delay and begin a new cycle. Any decisions regarding missed doses should be made in consultation with the treating oncologist.
Overdose
There is limited clinical experience with ELZONRIS overdose. In the event of an overdose, the patient should be closely monitored for signs and symptoms of adverse reactions, particularly capillary leak syndrome, hepatotoxicity, and severe hematologic toxicity. There is no specific antidote for tagraxofusp-erzs. Treatment of overdose should be supportive, with aggressive management of CLS symptoms (intravenous fluids, albumin replacement, vasopressors if needed), hepatotoxicity monitoring, and hematologic support (platelet and red blood cell transfusions as required).
Withhold ELZONRIS if: Serum albumin < 3.2 g/dL, AST or ALT > 5x upper limit of normal, severe hypersensitivity, or severe CLS symptoms. Do not resume until toxicity resolves to Grade 1 or baseline and albumin recovers to ≥ 3.2 g/dL. Permanently discontinue for life-threatening CLS, hepatotoxicity not resolving within 7 days, or severe anaphylaxis.
What Are the Side Effects of ELZONRIS?
The most common side effects of ELZONRIS include capillary leak syndrome, elevated liver enzymes, nausea, fatigue, peripheral edema, fever, and weight gain. Serious adverse effects include CLS, hepatotoxicity, and thrombocytopenia. Patients should report any unusual symptoms to their healthcare team immediately.
Like all cancer therapies, ELZONRIS can cause side effects ranging from mild to life-threatening. The side effect profile of ELZONRIS reflects both its targeted mechanism of action (killing CD123-expressing cells) and its broader effects on the body. In the pivotal clinical trial, the most frequently reported adverse reactions were capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, and elevated transaminases. Many side effects are manageable with appropriate supportive care, dose modifications, and monitoring.
The side effects listed below are based on data from clinical trials involving patients treated with ELZONRIS at the recommended dose. The frequency categories follow the standard classification used by regulatory agencies: very common (affects more than 1 in 10 patients), common (affects 1 in 10 to 1 in 100), uncommon (affects 1 in 100 to 1 in 1,000), and rare (affects fewer than 1 in 1,000).
Very Common (affects more than 1 in 10 patients)
- Capillary leak syndrome - fluid leakage from blood vessels causing swelling, low blood pressure, and low albumin (up to 55%)
- Elevated transaminases (ALT/AST) - liver enzyme increases indicating liver stress (up to 84%)
- Nausea - feeling of sickness or upset stomach (up to 45%)
- Fatigue - unusual tiredness, weakness, and lack of energy (up to 44%)
- Peripheral edema - swelling of hands, feet, ankles, and legs (up to 42%)
- Pyrexia - fever (up to 41%)
- Weight increase - gain of body weight related to fluid retention (up to 35%)
- Thrombocytopenia - low platelet count increasing bleeding risk (up to 49%)
- Anemia - low red blood cell count causing tiredness and pallor (up to 47%)
- Hypoalbuminemia - low blood albumin levels (up to 55%)
- Chills - shivering and feeling cold (up to 32%)
- Headache - pain or pressure in the head (up to 27%)
- Hypotension - dangerously low blood pressure (up to 29%)
Common (affects 1 in 10 to 1 in 100 patients)
- Dizziness - feeling faint or lightheaded
- Tachycardia - rapid heart rate
- Decreased appetite - reduced desire to eat
- Myalgia - muscle pain or aches
- Arthralgia - joint pain
- Rash - skin changes including redness, bumps, or itching
- Dyspnea - difficulty breathing or shortness of breath
- Hyponatremia - low sodium levels in blood
- Hypocalcemia - low calcium levels
- Neutropenia - low neutrophil count increasing infection risk
Uncommon (affects 1 in 100 to 1 in 1,000 patients)
- Anaphylaxis - severe allergic reaction requiring emergency treatment
- Tumor lysis syndrome - metabolic complications from rapid cancer cell death
- Disseminated intravascular coagulation (DIC) - abnormal blood clotting throughout the body
- Renal failure - decreased kidney function
Rare (affects fewer than 1 in 1,000 patients)
- Fatal capillary leak syndrome - life-threatening fluid leakage not responsive to treatment
- Fulminant hepatic failure - severe, rapid-onset liver failure
Contact your healthcare team immediately if you experience: sudden weight gain (more than 2 kg in 24 hours), swelling of the face, arms, or legs, dizziness or fainting, rapid heartbeat, severe nausea or vomiting, dark urine or yellowing of the skin (jaundice), unusual bruising or bleeding, difficulty breathing, high fever, or any signs of severe allergic reaction. These may indicate serious complications requiring urgent medical intervention.
How Should You Store ELZONRIS?
ELZONRIS must be stored frozen at -20°C (-4°F) or below in the original carton to protect from light. Once thawed, the diluted solution should be used within 4 hours. ELZONRIS is handled exclusively by healthcare professionals in hospital settings and is not stored at home.
ELZONRIS is a biological product that requires strict storage conditions to maintain its stability and efficacy. Because the drug is administered exclusively in clinical settings, patients will not typically be responsible for storage. However, understanding the storage requirements provides important context about the nature of this medication.
The vials of ELZONRIS concentrate must be stored frozen at -20°C (-4°F) or colder. The vials should be kept in the original carton to protect the product from light. ELZONRIS is a clear, colorless to slightly yellow solution. It should not be used if the solution is discolored, cloudy, or contains visible particles after thawing.
Before administration, ELZONRIS must be thawed and diluted. The thawing process should be performed in a controlled manner, and the diluted solution must be used within 4 hours of preparation when stored at room temperature (20-25°C / 68-77°F), or within 24 hours if refrigerated at 2-8°C (36-46°F). Once thawed, the vial should not be refrozen.
- Storage temperature: -20°C (-4°F) or colder, frozen
- Light protection: Store in original carton
- After dilution (room temp): Use within 4 hours
- After dilution (refrigerated): Use within 24 hours
- Do not refreeze once thawed
- Keep out of reach of children
- Do not use after the expiry date printed on the carton
What Does ELZONRIS Contain?
ELZONRIS contains the active ingredient tagraxofusp-erzs, a recombinant fusion protein of human interleukin-3 and truncated diphtheria toxin. Inactive ingredients include trometamol (tromethamine), sodium chloride, and sorbitol. Each vial contains 1 mg/mL of tagraxofusp-erzs.
ELZONRIS is a uniquely engineered biologic drug. The active substance, tagraxofusp-erzs, is a recombinant cytotoxin that combines two functional components into a single protein molecule. Understanding the composition helps patients and healthcare providers appreciate both the mechanism of action and potential sources of adverse reactions.
Active Ingredient
Tagraxofusp-erzs is the International Nonproprietary Name (INN) for the active substance. It is produced using recombinant DNA technology in an Escherichia coli (E. coli) expression system. The molecule consists of:
- Human interleukin-3 (IL-3): The targeting component that binds to CD123 (IL-3 receptor alpha chain) on the surface of BPDCN cells
- Truncated diphtheria toxin: The cytotoxic payload that inhibits protein synthesis by catalyzing ADP-ribosylation of elongation factor 2, causing cell death
The molecular weight of tagraxofusp-erzs is approximately 58 kilodaltons (kDa). Each single-dose vial contains 1 mL of solution at a concentration of 1 mg/mL (1,000 mcg/mL).
Inactive Ingredients (Excipients)
The formulation of ELZONRIS includes the following inactive ingredients, each serving a specific role in maintaining the stability and proper pH of the solution:
- Trometamol (tromethamine): A buffering agent that maintains the solution at the appropriate pH for stability and administration
- Sodium chloride: Provides osmotic balance (isotonicity) to make the solution compatible with intravenous administration
- Sorbitol: A sugar alcohol that acts as a stabilizer, helping to maintain the structural integrity of the protein during storage and handling
Patients with known hypersensitivity to any of the inactive ingredients (trometamol, sodium chloride, or sorbitol) should inform their healthcare provider. The diphtheria toxin component may also be a concern for patients with known severe allergies to diphtheria toxin-based products. ELZONRIS does not contain preservatives, latex, or animal-derived gelatin.
Frequently Asked Questions About ELZONRIS
ELZONRIS (tagraxofusp-erzs) is used for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive blood cancer. It was the first therapy specifically approved by the FDA for BPDCN in adults and pediatric patients aged 2 years and older. BPDCN typically presents with skin lesions and may involve bone marrow, blood, and lymph nodes. ELZONRIS targets CD123 (interleukin-3 receptor alpha chain) which is overexpressed on BPDCN tumor cells, delivering a cytotoxic payload that kills the cancer cells.
Capillary leak syndrome (CLS) is a serious and potentially fatal condition where fluid leaks from blood vessels into surrounding tissues. It is the most significant risk associated with ELZONRIS and carries a boxed warning on the prescribing information. Symptoms include hypotension (low blood pressure), swelling (edema), rapid weight gain, and low blood albumin levels. CLS occurred in approximately 55% of patients in clinical trials. Before each ELZONRIS infusion, serum albumin must be at least 3.2 g/dL. The first treatment cycle must be administered in an inpatient setting with monitoring for at least 24 hours after each dose.
ELZONRIS is administered as an intravenous (IV) infusion over approximately 15 minutes. The recommended dose is 12 micrograms per kilogram of body weight, given once daily on days 1 through 5 of each 21-day cycle. Before each infusion, patients receive pre-medication including an H1 antagonist (e.g., diphenhydramine), an H2 antagonist (e.g., famotidine), a corticosteroid (e.g., dexamethasone), and acetaminophen, given approximately 60 minutes before the infusion. The first cycle must be in an inpatient setting, while subsequent cycles may be given as outpatient if well tolerated.
The most common side effects of ELZONRIS include capillary leak syndrome (55%), elevated liver enzymes/transaminases (up to 84%), nausea (45%), fatigue (44%), peripheral edema or swelling (42%), fever (41%), thrombocytopenia or low platelet count (49%), anemia (47%), weight increase (35%), chills (32%), and hypotension (29%). Many of these side effects are manageable with supportive care and dose modifications. Patients should report any new or worsening symptoms to their healthcare team promptly.
ELZONRIS is not a traditional chemotherapy drug. It is classified as a CD123-directed cytotoxin, which is a type of targeted therapy. Unlike conventional chemotherapy, which affects all rapidly dividing cells indiscriminately, ELZONRIS is engineered to specifically target cells expressing CD123 on their surface. It consists of human interleukin-3 fused to a truncated diphtheria toxin. When it binds to CD123-positive cells, it delivers the toxin payload directly to those cells. However, it does cause significant immunosuppression and hematologic toxicity that may be similar to what is seen with chemotherapy.
In the pivotal clinical trial (Study 0901-14-002), ELZONRIS demonstrated a complete response (CR) or clinical complete response (CRc) rate of approximately 72% in treatment-naive patients with BPDCN. The median overall survival was approximately 33.4 months in previously untreated patients. These results represented a significant improvement over historical outcomes for BPDCN, which typically had a median survival of 12-14 months with conventional chemotherapy regimens. Some patients achieved durable remissions lasting more than 2 years.
References
- U.S. Food and Drug Administration. ELZONRIS (tagraxofusp-erzs) Prescribing Information. Silver Spring, MD: FDA; 2018 (revised 2023). Available at: FDA.gov
- European Medicines Agency. ELZONRIS (tagraxofusp) Summary of Product Characteristics. Amsterdam: EMA; 2021. Available at: EMA.europa.eu
- Pemmaraju N, Lane AA, Sweet KL, et al. Tagraxofusp in Blastic Plasmacytoid Dendritic-Cell Neoplasm. N Engl J Med. 2019;380(17):1628-1637. doi:10.1056/NEJMoa1815105
- 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(3):385-392. doi:10.1182/blood-2014-04-566737
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). Version 1.2024. Available at: NCCN.org
- World Health Organization. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. 5th ed. Lyon: IARC Press; 2022.
- Garnache-Ottou F, Voisin S, Vitte F, et al. Expression of the myeloid-associated marker CD33 is not an exclusive factor for leukemic plasmacytoid dendritic cells. Blood. 2005;105(3):1256-1264.
- Pemmaraju N, Konopleva M. Approval of tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm. Blood Adv. 2020;4(16):4020-4027.
- British National Formulary (BNF). Tagraxofusp. National Institute for Health and Care Excellence (NICE). 2024.
- Sapienza MR, Pileri A, Derenzini E, et al. Blastic Plasmacytoid Dendritic Cell Neoplasm: State of the Art and Prospects. Cancers. 2019;11(5):595.
About This Article
This article has been written and medically reviewed by the iMedic Medical Editorial Team, which includes specialists in oncology, hematology, and clinical pharmacology. All medical information is based on peer-reviewed research, FDA and EMA prescribing information, and international clinical guidelines.
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iMedic Medical Editorial Team
Specialists in oncology, hematology, and pharmacology with documented academic background and clinical experience
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iMedic Medical Review Board
Independent panel of medical experts reviewing content according to international guidelines (FDA, EMA, NCCN, WHO)