Menarini Group & VisualDx: New Collaboration
- FLORENCE, Italy and NEW YORK, March 20, 2025 – In a collaborative effort to improve the early detection of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), The Menarini Group...
- visualdx, a physician-led company, is dedicated to enhancing medical decision-making, education, and research.
- BPDCN, an aggressive hematologic malignancy, presents with skin lesions and can involve the bone marrow, blood, central nervous system, lymph nodes, and viscera.
- BPDCN is an aggressive hematologic malignancy with a historically poor prognosis
- VisualDx is a clinical decision support system used by more than 2,300 hospitals, clinics, and medical
schools around the world
- VisualDx’s system seeks to enhance identification of people who may have BPDCN, leveraging actual images of
BPDCN skin lesions and artificial intelligence/machine learning (AI/ML) technologies incorporated into the
visualdx platform
FLORENCE, Italy and NEW YORK, March 20, 2025 – In a collaborative effort to improve the early detection of
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), The Menarini Group and Stemline Therapeutics, Inc. are
partnering with VisualDx. This collaboration aims to integrate artificial intelligence (AI) to identify BPDCN as an
early differential diagnosis. The project leverages images of BPDCN skin lesions and AI/ML technologies within the
VisualDx platform, with the AI model now live within VisualDx.
visualdx, a physician-led company, is dedicated to enhancing medical decision-making, education, and research. Their
clinical decision support system is utilized in over 2,300 medical facilities globally. The software features a
extensive database of clinical images, vetted by clinicians, to aid healthcare professionals in identifying skin
concerns across all skin types. Through AI image search, clinicians can better understand skin conditions, supporting
more accurate diagnoses.
BPDCN, an aggressive hematologic malignancy, presents with skin lesions and can involve the bone marrow, blood,
central nervous system, lymph nodes, and viscera. Dermatologists are frequently enough the first to recognise signs of BPDCN
and biopsy suspicious lesions.Pathologists can then test for BPDCN using biomarkers highly expressed on BPDCN
cells. Tagraxofusp-erzs is the only approved treatment for BPDCN in the United States, Europe, and other regions.
According to Marina Konopleva, MD, Phd, Professor, Molecular Pharmacology, Director, Leukemia Program and
Co-Director, Blood Cancer Institute, at Montefiore Einstein, BPDCN is a rare and clinically aggressive hematologic
malignancy, often presenting with cutaneous lesions. Due to its aggressive nature and the immature cell
involvement, the prognosis can be poor if not treated promptly.Early diagnosis plays a critical role in improving
patient outcomes, and emerging AI/ML technologies may offer valuable support in the differential diagnosis and
early identification of BPDCN.
Elcin Barker Ergun, CEO of the Menarini Group, stated, BPDCN often first presents as a skin lesion and usually has
a poor prognosis. There is a dire need for early diagnosis so that patients may access appropriate treatment
options. We are delighted to collaborate with VisualDx to provide healthcare teams with a tool using the latest
artificial intelligence/machine learning (AI/ML) technology to help interpret challenging skin lesions.
visualdx ensures patient privacy by not storing any images uploaded by clinicians.
About BPDCN
BPDCN, formerly blastic NK-cell lymphoma, is an aggressive hematologic malignancy with cutaneous manifestations and
poor outcomes. It typically presents with skin lesions and may involve bone marrow, blood, central nervous system,
lymph nodes, and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. Diagnosis is
based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, and also other markers. The world
Health Institution (WHO) termed this disease “BPDCN” in 2008.
About ELZONRIS® (Tagraxofusp-erzs)
U.S.Indication: ELZONRIS is a prescription medicine used to treat blastic plasmacytoid dendritic cell
neoplasm (BPDCN) in adults and pediatric patients 2 years and older.
Full prescribing information for the U.S.can be found at www.elzonris.com
IMPORTANT SAFETY INFORMATION, ELZONRIS®
Boxed WARNING: CAPILLARY LEAK SYNDROME
- 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.
Warnings and Precautions
Capillary Leak Syndrome
Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported
among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials,the overall incidence of CLS
was 53% (65/122),including Grade 1 or 2 in 43% (52/122) of patients,Grade 3 in 7% (8/122) of patients,Grade 4 in
1% (1/122) of patients,and four fatalities (3%).The median time to onset was 4 days (range – 1 to 46 days), and all
but 5 patients experienced an event in Cycle 1.
Before initiating therapy with ELZONRIS,ensure that the patient has adequate cardiac
function and serum albumin is greater than or equal to 3.2 g/dL. During treatment with ELZONRIS, monitor serum
albumin levels prior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess
patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including
pulmonary edema, hypotension or hemodynamic instability.
Hypersensitivity Reactions
ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in
clinical trials,hypersensitivity reactions were reported in 43% (53/122) of patients treated with ELZONRIS and were
Grade ≥ 3 in 7% (9/122). Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, and
stomatitis. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS
infusion and provide supportive care as needed if a hypersensitivity reaction should occur.
Hepatotoxicity
Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients
receiving ELZONRIS in clinical trials, elevations in ALT occurred in 79% (96/122) and elevations in AST occurred in
76% (93/122). Grade 3 ALT elevations were reported in 26% (32/122) of patients. Grade 3 AST elevations were reported
in 30% (36/122) and Grade 4 AST elevations were reported in 3% (4/122) of patients. Elevated liver enzymes occurred
in the majority of patients in Cycle 1 and were reversible following dose interruption.
monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each
infusion with ELZONRIS. Withhold ELZONRIS temporarily if the transaminases rise to greater than 5 times the upper
limit of normal and resume treatment upon normalization or when resolved.
Adverse Reactions
Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea,
fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are
decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST.
Please see full Prescribing
Information, including Boxed WARNING.
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.
About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.7
billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for
cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia.
With 18 production sites and 9 Research and Development centers, Menarini’s products are available in 140 countries
worldwide. For further information, please visit menarini.com.
About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage
biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline
commercializes elacestrant, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men
with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated
advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the
U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy
directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive
hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes
selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion
studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an
extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and
hematologic cancers.
About VisualDx
VisualDx is a company dedicated to improving medical decisions through augmented thinking and timely visualization. It
is committed to reducing disparities in medicine and believes technology can bridge gaps in knowledge to bring about
more equitable care. VisualDx has become the standard professional resource at more than 2,300 hospitals, clinics and
medical schools worldwide by combining problem oriented clinical search with the world’s best curated medical image
library, plus medical knowledge from experts and elegant machine learning algorithms to help with differential
diagnosis, variation, treatment, and patient dialog. Learn more at www.visualdx.com
1 Pagano L, et al Haematological. 2013;98 (2): 239-246 and Pemmaraju N Curr Hematol Malig Rep. 2017; 12(6):
510-512
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) and AI: A Q&A Guide
Table of Contents
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) and AI: A Q&A Guide
- What is Blastic plasmacytoid dendritic Cell Neoplasm (BPDCN)?
- Why is Early Diagnosis of BPDCN Important?
- Common Questions about BPDCN Answered:
- What are the First Signs of BPDCN?
- how is BPDCN Diagnosed?
- What is the Standard Treatment for BPDCN?
- What is ELZONRIS® (Tagraxofusp-erzs)?
- What are the Critically important Safety Warnings for ELZONRIS?
- What are the Main Side Effects of ELZONRIS?
- How is Artificial Intelligence (AI) Helping in BPDCN Diagnosis?
- What is VisualDx?
- How does VisualDx ensure patient privacy?
- BPDCN: Key Facts Summarized
- The Future of BPDCN Diagnosis and Treatment
Blastic plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a rare and aggressive type of blood cancer. Recent advances in technology, especially artificial intelligence (AI), offer new hope for earlier and more accurate diagnosis. This article explores BPDCN, its diagnosis and treatment, and the role of AI in improving patient outcomes.
What is Blastic plasmacytoid dendritic Cell Neoplasm (BPDCN)?
BPDCN is an aggressive hematologic malignancy,meaning it affects the blood and bone marrow. It frequently enough presents with skin lesions but can also involve other organs, including the:
Bone marrow
Blood
Central nervous system
Lymph nodes
Viscera
Previously known as blastic NK-cell lymphoma, the World Health Organization (WHO) officially termed this disease “BPDCN” in 2008.
Why is Early Diagnosis of BPDCN Important?
Early diagnosis is crucial for improving patient outcomes. As BPDCN is an aggressive cancer, prompt treatment is necesary to improve prognosis. According to Marina konopleva, MD, PhD, from Montefiore Einstein, the prognosis can be poor if BPDCN is not treated promptly due to its aggressive nature.
Early BPDCN diagnosis plays a critical role in improving patient outcomes, and emerging AI/ML technologies may offer valuable support in the differential diagnosis and early identification of BPDCN.
Common Questions about BPDCN Answered:
What are the First Signs of BPDCN?
The initial signs of BPDCN frequently enough involve skin lesions. These lesions can vary in appearance, making diagnosis challenging. Given this, dermatologists often play a critical role in recognizing suspicious lesions and performing biopsies.
how is BPDCN Diagnosed?
Diagnosis is based on identifying specific markers on the BPDCN cells through immunophenotyping.This typically involves identifying the diagnostic triad of CD123, CD4, and CD56, along with other markers. Pathologists perform these tests on biopsies.
What is the Standard Treatment for BPDCN?
Tagraxofusp-erzs, marketed as ELZONRIS, is currently the only approved treatment for BPDCN in the United States, Europe, and other regions.
What is ELZONRIS® (Tagraxofusp-erzs)?
ELZONRIS is a prescription medicine used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients 2 years and older.
What are the Critically important Safety Warnings for ELZONRIS?
ELZONRIS carries a boxed warning for Capillary Leak syndrome (CLS). Here’s a summary:
Capillary Leak Syndrome (CLS): Can be life-threatening or fatal. monitor for signs and symptoms.
Hypersensitivity Reactions: Severe reactions can occur. Monitor patients and interrupt infusion if needed.
Hepatotoxicity: Can cause elevations in liver enzymes (ALT and AST). Monitor liver function.
What are the Main Side Effects of ELZONRIS?
The most common adverse reactions (incidence ≥ 30%) are:
Capillary leak syndrome
Nausea
Fatigue
Pyrexia (fever)
Peripheral edema
Weight increase
common lab abnormalities (incidence ≥ 50%) include:
Decreases in albumin, platelets, hemoglobin, calcium, and sodium
Increases in glucose, ALT, and AST
How is Artificial Intelligence (AI) Helping in BPDCN Diagnosis?
AI, particularly through platforms like VisualDx, is being used to enhance the early detection of BPDCN. VisualDx’s system incorporates:
Image Database: A large collection of clinical images of BPDCN skin lesions.
AI/ML Technologies: Algorithms that analyze images to identify potential cases of BPDCN.
By leveraging AI, clinicians can improve their ability to recognize BPDCN in its early stages, leading to faster diagnosis and treatment. According to Elcin Barker Ergun,CEO of the Menarini Group,this technology can help interpret challenging skin lesions.
What is VisualDx?
VisualDx is a clinical decision support system utilized by over 2,300 hospitals, clinics, and medical schools worldwide.It helps healthcare professionals identify skin concerns across all skin types, enhancing medical decision-making, education, and research.
How does VisualDx ensure patient privacy?
VisualDx ensures patient privacy by not storing any images uploaded by clinicians.
BPDCN: Key Facts Summarized
| Feature | Description |
| —————————– | —————————————————————————————————————————————————- |
| Disease | Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) – an aggressive hematologic malignancy. |
| Early Signs | Often presents with skin lesions. |
| Diagnosis | Immunophenotyping to identify markers such as CD123, CD4, and CD56. |
| Treatment | Tagraxofusp-erzs (ELZONRIS) is the only approved treatment. |
| role of AI | AI, like VisualDx, aids in early detection by analyzing skin lesion images. |
| VisualDx | Clinical decision support system used globally, leveraging AI to enhance diagnostic accuracy. |
The Future of BPDCN Diagnosis and Treatment
Collaborative efforts, such as the partnership between The Menarini Group, Stemline Therapeutics, and VisualDx, show a promising path forward. By integrating AI into diagnostic tools, healthcare professionals can improve early detection and ultimately improve patient outcomes for this aggressive malignancy.