Tagraxofusp-erzs (ELZONRIS ® )
The only FDA-approved treatment for BPDCN recommended in
the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ) 1
®
A potent, targeted treatment for a deadly hematologic cancer 2-4
ELZONRIS targets and binds to cd 123, inducing cell death 2
cd 123
is highly expressed (~95%) on BPDCN cells 5-8
The largest prospective clinical study of patients with BPDCN 2,9
ELZONRIS was evaluated in treatment-naïve and previously-treated patients with BPDCN in an open-label,
multicenter clinical study (STML-401-0114) of patients receiving 12 mcg/kg of ELZONRIS (N=44).
The pivotal cohort consisted of 13 treatment-naïve patients.
ELZONRIS delivered durable efficacy in treatment-naïve patients (n=29) 9
72
% 90
CR/CRc rate* ORR
45
%
%
bridged to stem cell
transplantation
Median duration of CR/CRc has not yet been reached;
median follow-up 19 months (range, 1-42 months). 9
In the pivotal cohort, treatment-naïve patients (n=13)
achieved a 54% CR/CRc rate, 77% ORR, and 46%
bridged to stem cell transplantation. 2,3
* CRc = clinical complete response; defined as complete response with residual skin abnormality not indicative of active disease. 2
BPDCN = blastic plasmacytoid dendritic cell neoplasm; NCCN = National Comprehensive Cancer Network; CR = complete response; ORR = overall
response rate.
Recommended in the NCCN Guidelines
®
INDICATION
• 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
IMPORTANT SAFETY INFORMATION
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
• 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
• Before initiating therapy with ELZONRIS, ensure that the patient
has adequate cardiac function and serum albumin is ≥ 3.2 g/dL
• 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
• Counsel patients to seek immediate medical attention should
signs or symptoms of CLS occur at any time
Hypersensitivity Reactions
• 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
Please see Brief Summary of full Prescribing Information, including Boxed WARNING, on the following pages.