Elzonris (tagraxofusp-erzs) / Menarini 
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 17 Diseases   11 Trials   11 Trials   832 News 


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  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Review, Journal:  Diagnostic approach to blastic plasmacytoid dendritic cell neoplasm: historical perspectives and current understanding. (Pubmed Central) -  Mar 31, 2025   
    The emergence of tagraxofusp, a CD123-directed cytotoxin, and other novel therapies has underscored the importance of accurately diagnosing BPDCN...Lastly, we discussed pDC-AML, characterized by pDC proliferation in AML cases, which can also be part of MPDCP and is often associated with frequent RUNX1 mutations. Overall, this review provides insights into BPDCN diagnosis and highlights the current challenges in its detection and differential diagnosis.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Review, Journal, IO biomarker:  Immunotherapies Targeting CD123 and CD303: A New Frontier in Treating Blastic Plasmacytoid Dendritic Cell Neoplasm. (Pubmed Central) -  Mar 27, 2025   
    Tagraxofusp, the first FDA-approved CD123-targeted therapy, has significantly improved patient outcomes...This review explores the latest developments in BPDCN treatment, emphasizing the potential of CD123 and CD303 as targets for precision medicine interventions. The ongoing evolution of targeted immunotherapies holds promise for improving patient survival and redefining treatment paradigms in hematologic malignancies.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Enrollment open, Trial primary completion date:  Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML (clinicaltrials.gov) -  Feb 11, 2025   
    P1/2,  N=20, Recruiting, 
    Trial completion date: Jan 2027 --> Apr 2027 | Trial primary completion date: Jan 2027 --> Apr 2027 Not yet recruiting --> Recruiting | Trial primary completion date: Oct 2026 --> Oct 2027
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Journal:  Advancing the understanding and management of blastic plasmacytoid dendritic cell neoplasm: Insights from recent case studies. (Pubmed Central) -  Nov 7, 2024   
    Furthermore, we explore the implications of these findings for management strategies, emphasizing the use of targeted therapies such as tagraxofusp and the potential of allogeneic haematopoietic stem cell transplantation in achieving remission. The editorial underscores the importance of interdisciplinary approaches in managing BPDCN, pointing towards a future where precision medicine could significantly improve patient outcomes.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Tagraxofusp Achieves Anti-Tumor Activity with Rapid Restoration of Normal Hematopoiesis in Treatment-Na (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2882;    
    P1/2
    Conclusions As demonstrated previously, TAG offers rapid and durable responses in front-line treated BPDCN patients. The observed safety profile, lack of cumulative myelosuppression, and restoration of normal hematopoiesis with TAG treatment support the efficacy and tolerability of TAG as monotherapy for BPDCN and makes TAG a safe and promising combination partner for treatment of other CD123+ hematologic malignancies.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry: Tagraxofusp Cohort Treatment Results (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2842;    
    This therapy is currently only available in selected countries and only 3 out of the 13 countries participating in this registry reported its use. The treatment strategy of BPDCN should be a total therapy approach incorporating novel agents like tagraxofusp with intrathecal chemotherapy and allo-SCT to prevent the relapse.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    HLA-Pan-DP CAR-T Demonstrates Cytotoxicity Against Multiple Hematological Malignancies (Room 6CF (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1616;    
    Conclusion : Anti-HLA-pan-DP CAR-T is a promising candidate for further preclinical development for the treatment of various HLA-DP positive hematological malignancies such as B-cell lymphomas, MM, and particularly BPDCN, for which there are no effective treatments except for CD123 targeted immunotherapy (SL-401). Due to expected suppression of normal hematopoiesis by HLA-pan-DP CAR-T, this approach would likely be best-implemented as a bridge to hematopoietic stem cell transplantation.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Machine Learning Derived Three-Parameter Prognostic Model for Survival in Patients with BPDCN (Seaport Ballroom EFGH (Manchester Grand Hyatt San Diego)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1350;    
    Due to expected suppression of normal hematopoiesis by HLA-pan-DP CAR-T, this approach would likely be best-implemented as a bridge to hematopoietic stem cell transplantation. Therapeutic options include tagraxofusp, the first and only drug specifically approved for BPDCN, as well as regimens developed for acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and lymphoma...We generated a prognostic model for patients with BPDCN based on age, bone marrow involvement and presence of signaling mutations, with 3 risk groups
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Elzonris (tagraxofusp-erzs) / Menarini
    Treatment Approaches for Blastic Plasmacytoid Dendritic Cell Neoplasm: Data from the Pethema and PALG Epidemiologic Registry (Seaport Ballroom EFGH (Manchester Grand Hyatt San Diego)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1349;    
    The non-intensive group included 21 (40%) AML-like regimens (10 AZA, 5 AZA-VEN, 4 LDAC, and 2 fludarabine+LDAC); 18 (34%) CD123 or CD33 targeted molecules, 9 (16%) ALL-like therapies (vincristine and dexamethasone-based), and 5 (10%) lymphoma-like, including 3 with radiotherapy or intralesional chemotherapy...The differences between treatment subgroups, such as age at diagnosis, among others, could influence the differences in OS. Larger studies and observational protocols are needed to identify best upfront regimens for BPDCN.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Journal:  Blast and Bursts: Unveiling Splenic Rupture in Blastic Plasmacytoid Dendritic Cell Neoplasia. (Pubmed Central) -  Oct 14, 2024   
    This case emphasizes the challenges of diagnosing and treating BPDCN, noting its rarity and absence of standard therapy. Tagraxofusp has shown promising results but presents safety concerns like capillary leak syndrome, particularly in elderly patients with comorbidities.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Chasing Zebras: Navigating Rare Myeloid Neoplasms (Grand Hall C (Manchester Grand Hyatt San Diego); Virtual) -  Oct 5, 2024 - Abstract #ASH2024ASH_706;    
    In the final talk of this session, Dr Olga Weinberg very nicely draws attention to acute leukemias of ambiguous lineage, a field that is rapidly growing as it benefits from deeper, faster, and more directed targeted sequencing efforts and improved patho-biologic understanding of the various subsets that make up this unique entity. Among the keys to this topic will be understanding several of the newer tests, at the level of the blood, bone marrow, flow cytometry, cytogenetics and molecular next generation sequencing that are available in the pathologists
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Journal, Monotherapy, Real-world evidence, Real-world:  Overcoming Tagraxofusp-Erzs Monotherapy Resistance in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in a Real-World Clinical Setting. (Pubmed Central) -  Sep 2, 2024   
    Currently, standard treatment strategies include clinical trials; chemotherapy regimens such as hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HCVAD); and tagraxofusp-erzs (TAG, previously SL-401) which is the first-in-class targeted therapy against CD123...However, despite promising results, there are still patients who may be resistant to TAG monotherapy and/or who respond but eventually relapse. Herein, we discuss an important patient case of BPDCN treated with TAG and review BPDCN treatment strategies.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Blastic Plasmocytoid dendritic cell neoplasm and Down Syndrome (Poster Area) -  Aug 5, 2024 - Abstract #EADV2024EADV_3024;    
    The prognosis is poor, with a median survival of 8 to 16 months, and treatment is complex, characterized by resistance to standard chemotherapy. Treatment options are hyperCVAD and CHOP, which are therapeutic options for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Lymphoma.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Trial termination:  Tagraxofusp in Treating Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm After Stem Cell Transplant (clinicaltrials.gov) -  Jul 30, 2024   
    P2,  N=3, Terminated, 
    The current document delineates a case of a 14-year-old female patient contending with blastic plasmacytoid dendritic cell neoplasm, whose primary symptom was a mammary nodule, and whose breast and bone marrow/blood involvement were synchronous, in attempt to increase clinical vigilance. Completed --> Terminated; The protocol was terminated early due to slow participant accrual and the sponsor not willing to provide the study drug.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Review, Journal:  Blastic Plasmacytoid Dendritic Cell Neoplasm, from a Dermatological Point of View. (Pubmed Central) -  Jul 13, 2024   
    Treatment options range from conventional chemotherapy to the recently approved biologic agent tagraxofusp and stem cell transplantation. Therefore, a multidisciplinary approach with coordination among dermatologists, pathologists, and hematologists is ultimately imperative to reach the correct diagnosis and management of BPDCN.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini, Nippon Shinyaku
    Review, Journal:  Tagraxofusp, a first-in-class CD123-targeted agent: Five-year postapproval comprehensive review of the literature. (Pubmed Central) -  Jun 8, 2024   
    The successful targeting of CD123 in BPDCN has also encouraged research into a variety of other CD123-positive hematological neoplasms, including acute myeloid leukemia (AML), and informed the development of other novel agents targeting CD123. This review examines the clinical data leading to the development and approval of tagraxofusp in BPDCN, how it is being used in combination to improve outcomes in BPDCN and AML, and its developing role in other hematological malignancies.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini, Nippon Shinyaku
    Enrollment change, Trial withdrawal:  Tagraxofusp to Eradicate Measurable Residual Disease in Patients With Acute Myeloid Leukemia (clinicaltrials.gov) -  Mar 12, 2024   
    P1,  N=0, Withdrawn, 
    With proper selection, monitoring, and directed intervention, CLS is manageable, usually mild, limited to the first cycle, and does not recur. N=29 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, pivekimab sunirine (IMGN632) / Jazz, Elzonris (tagraxofusp) / Menarini, Nippon Shinyaku
    Review, Journal:  Breakthrough in Blastic Plasmacytoid Dendritic Cell Neoplasm Cancer Therapy Owing to Precision Targeting of CD123. (Pubmed Central) -  Feb 14, 2024   
    The exploration of combinations such as CD123-targeted immunotherapies with azacitidine and venetoclax is suggested to enhance antineoplastic responses and improve survival rates in BPDCN patients. In conclusion, this multifaceted approach offers hope for more effective and tailored therapeutic interventions against this challenging hematologic malignancy.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Elzonris (tagraxofusp) / Menarini, Nippon Shinyaku
    Review, Journal:  Blastic Plasmacytoid Dendritic Cell Neoplasm: A Comprehensive Review of the Disease, Central Nervous System Presentations, and Treatment Strategies. (Pubmed Central) -  Feb 9, 2024   
    Tagraxofusp and traditional regimens for acute myeloid leukemia show limited success at preventing CNS relapse, prompting exploration of combined therapies like hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HyperCVAD) with venetoclax and adding IT chemotherapy to other backbones...Trials incorporating CNS-involved patients aim to pioneer novel treatment approaches, potentially reshaping BPDCN management. Understanding CNS involvement's complexities in BPDCN remains crucial for tailored treatments and better patient outcomes.