Drug updated on 6/11/2024
Dosage Form | Injection (intravenous; 1,000 mcg/1 mL) |
Drug Class | CD123-directed cytotoxins |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.
Latest News
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Summary
- Tagraxofusp-erzs (Elzonris) is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients aged 2 years and older. It targets CD123+ cells characteristic of BPDCN, providing a more tailored approach to managing this aggressive disease.
- Two studies focused on Elzonris' application in managing BPDCN emphasized its role as a landmark development due to its targeted nature and precision oncology approach.
- Before the introduction of Elzonris, management of BPDCN mainly involved remission induction therapy followed by stem cell transplant, a process often hampered by the difficulty in achieving sufficient remission with conventional chemotherapy. Elzonris, in contrast, presents a targeted therapy option specifically for this condition.
- Despite BPDCN occurring most frequently in patients over 60, it also affects children and adults of various ages. The introduction of Elzonris has been significant across all affected age groups, considering the historically complex diagnosis process, which often overlaps with other hematologic malignancies.
- Even though Elzonris is associated with a unique toxicity profile, predominately capillary leak syndrome (CLS), these adverse events can be managed with adequate patient selection and monitoring, making it an important option in the treatment landscape despite potential risks.
- Detailed clinical case studies have led to approval, demonstrating effectiveness against CD123+ cells. This marks a progression towards precision oncology, addressing unmet needs within this patient population without direct comparison to other specific drugs in controlled trials being available from the studies reviewed.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Elzonris (tagraxofusp-erzs) Prescribing Information. | 2022 | Stemline Therapeutics, Inc., New York, NY |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Recent advances in the biology and CD123-directed treatment of blastic plasmacytoid dendritic cell neoplasm. | 2024 | Clinical Lymphoma, Myeloma & Leukemia |
Tagraxofusp for blastic plasmacytoid dendritic cell neoplasm. | 2020 | Hematology/Oncology Clinics of North America |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN): focus on the use of tagraxofusp and clinical considerations. | 2024 | Leukemia & Lymphoma |
North American Blastic Plasmacytoid Dendritic Cell Neoplasm Consortium: Position on standards of care and areas of need. | 2023 | Blood |
Clinical insights into the Management of Blastic Plasmacytoid Dendritic Cell Neoplasm. | 2022 | Cancer Management and Research |
Approval of tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm. | 2020 | Blood Advances |