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The First and Only Approved Treatment for Blastic
Plasmacytoid Dendritic Cell Neoplasm (BPDCN) |
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FROM A DEADLY DISEASE
RISES A DURABLE RESPONSE |
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| Dear Healthcare Provider, |
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| ELZONRIS™ (tagraxofusp-erzs) is now approved for BPDCN, a deadly hematologic cancer that may exhibit variable dermatologic and hematologic presentations and is often mistaken for other malignancies.1-4 |
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ELZONRIS targets the CD123 receptor, which is highly expressed on BPDCN cells. In the largest prospective clinical trial of patients with BPDCN, ELZONRIS demonstrated durable efficacy in an
open-label, multicenter clinical study (N=44).1,5-9 |
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| Efficacy in treatment-naïve patients with BPDCN (N=29)9 |
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| 45% |
| bridged to stem cell |
| transplantation |
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CRc = clinical complete response; defined as complete response with residual skin abnormality not indicative of active disease.5
CR = complete response; ORR = overall response rate. |
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| Median duration of CR/CRc has not yet been reached (range, 1.3-32.2+ months).9 |
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| Median overall survival has not yet been reached; median follow-up 23.0 months (range, 0.2-41.0+ months).9 |
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| In the pivotal cohort, treatment-naïve patients (N=13) achieved a 54% CR/CRc rate, 77% ORR, and 46% bridged to stem cell transplantation.5,9 |
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| ELZONRIS was evaluated in treatment-naïve and previously-treated patients with BPDCN in an open-label, multicenter clinical study (N=44). The pivotal cohort consisted of 13 treatment-naïve patients.5,9 |
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| VISIT ELZONRIS.COM/HCP FOR MORE INFORMATION. |
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| INDICATION |
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ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older |
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| IMPORTANT SAFETY INFORMATION |
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| Boxed WARNING: CAPILLARY LEAK SYNDROME |
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Capillary Leak Syndrome (CLS), which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended |
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| WARNINGS AND PRECAUTIONS |
| Capillary Leak Syndrome |
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ELZONRIS can cause capillary leak syndrome (CLS), which may be life-threatening or fatal if not properly managed. The overall incidence of CLS in clinical trials was 55% in patients receiving ELZONRIS, including 46% in Grades 1 or 2, 6% in Grade 3, 1% in Grade 4, and 2 fatal events. Common signs and symptoms (incidence ≥ 20%) associated with CLS that were reported during treatment with ELZONRIS include hypoalbuminemia, edema, weight gain, and hypotension |
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Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is ≥ 3.2 g/dL |
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During treatment with ELZONRIS, ensure that serum albumin levels are ≥ 3.5 g/dL and have not been reduced by ≥ 0.5 g/dL from the albumin value measured prior to dosing initiation of the current cycle. Monitor serum albumin levels prior to the initiation of each dose or more often as indicated clinically thereafter. Additionally, assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema including pulmonary edema, hypotension, or hemodynamic instability |
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Counsel patients to seek immediate medical attention should signs or symptoms of CLS occur at any time |
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| Hypersensitivity Reactions |
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ELZONRIS can cause severe hypersensitivity reactions. Grade 3 or higher events were reported in 10% of patients in clinical trials. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur. If the reaction is severe, discontinue ELZONRIS permanently |
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| Hepatotoxicity |
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Elevations in liver enzymes can occur with ELZONRIS. Grade 3 or higher elevations in liver enzymes occurred in approximately 40% of patients in clinical trials |
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Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Temporarily withhold ELZONRIS if the transaminases rise to greater than 5 times the upper limit of normal (ULN) and resume treatment upon normalization or when resolved |
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| ADVERSE REACTIONS: |
| The most common adverse reactions in the clinical trials (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, and weight increase. The most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, sodium, and increases in glucose, ALT, and AST. |
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Please see full Prescribing Information, including
Boxed WARNING. |
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| To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. |
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| References: 1. Laribi K, Denizon N, Besançon A, et al. Blastic plasmacytoid dendritic cell neoplasm: from origin of the cell to targeted therapies. Biol Blood Marrow Transplant. 2016;22(8):1357-1367. 2. Riaz W, Zhang L, Horna P, Sokol L. Blastic plasmacytoid dendritic cell neoplasm: update on molecular biology, diagnosis, and therapy. Cancer Control. 2014;21(4):279-289. 3. Pagano L, Valentini CG, Grammatico S, Pulsoni A. Blastic plasmacytoid dendritic cell neoplasm: diagnostic criteria and therapeutical approaches. Br J Haematol. 2016;174(2):188-202. 4. León-Martínez G, Meillón-García L, Morales-Polanco M, Soler-Montecinos L, Ortiz-Hidalgo C. Unusual morphologic presentations of blastic plasmacytoid dendritic cell neoplasm: report of two cases misdiagnosed as melanoma and leprosy. Int J Surg Pathol. 2014;22(1):76-82. 5. ELZONRIS [prescribing information]. New York, NY, US: Stemline Therapeutics, Inc.; December 2018. 6. Facchetti F, Cigognetti M, Fisogni S, Rossi G, Lonardi S, Vermi W. Neoplasms derived from plasmacytoid dendritic cells. Mod Pathol. 2016;29(2):98-111. 7. 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. 8. Pagano L, Valentini CG, Pulsoni A, et al. Blastic plasmacytoid dendritic cell neoplasm with leukemic presentation: an Italian multicenter study. Haematologica. 2013;98(2):239-246. 9. Data on file. Stemline Therapeutics, Inc. |
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750 Lexington Avenue, New York, NY 10022
All rights reserved. 1/2019 US-ELZ-1800027 |
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