ASH News Daily 2017 - Issue 1 - A-24

HEMATOLOGY POST
74% ORR in Relapsed
Follicular Lymphoma
Patients Refractor y
to Rituximab

83% ORR in R/R Low-grade
or Follicular Lymphoma
Patients vs. 55% ORR with
Rituximab Alone (p<0.001)

Grade 3/4 adverse reactions for
relapsed or refractory NHL patients

Risk of serious infection in relapsed
or refractory NHL patients

Prolonged and severe cytopenias (thrombocytopenia [63%], neutropenia [60%],
anemia [17%], and ecchymosis [<1%])
and secondary malignancies (5.2%).
ZEVALI N therapeut ic regimen was evaluated in a single-arm study of 54 patients. Ritu ximab refractory was defined
as failu re to achieve a PR or CR or TTP
<6 months. The primary endpoint of this
study was ORR using the Inter national
Workshop Response Criteria.

Initial
Approval:
2002

Chemo-free
in the
relapsed /
refractory
setting

Serious infections occurred in 3% of
patients (urinary tract infection, febrile
neutropenia, sepsis, pneumonia, cellulitis, colitis, diarrhea, osteomyelitis,
and upper respiratory tract infection).
Life-threatening infections were reported in 2% of patients (sepsis,
empyema, pneumonia, febrile neutropenia, fever, and biliary stent-associated cholangitis).

It's not new.
But it may be
news to you.
Learn more at booth 423
or by visiting ZEVALIN.com

A randomized (1:1), open-label, mult icenter study of 130 patients compared the
ZEVALI N therapeut ic regimen (N=64)2
to rituximab (N=66) given 375 mg/m
IV week ly for four doses. The primary
endpoint of the study was ORR using the
Inter national Workshop Response Criteria.

Indications and Usage
ZEVALIN (ibritumomab tiuxetan) is a CD20-directed radiotherapeutic antibody administered
as part of the ZEVALIN therapeutic regimen indicated for the treatment of patients with:
* Relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).
* Previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy.

Important Safety Information
WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS,
and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS
Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN
therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial
infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. Discontinue
rituximab and Y-90 ZEVALIN infusions in patients who develop severe infusion reactions.
Prolonged and Severe Cytopenias: Y-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Do not
administer Y-90 ZEVALIN to patients with ≥25% lymphoma marrow involvement and/or impaired bone marrow reserve.
Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the
ZEVALIN therapeutic regimen. Discontinue rituximab and Y-90 ZEVALIN infusions in patients experiencing severe cutaneous or
mucocutaneous reactions.
Dosing: The dose of Y-90 ZEVALIN should not exceed 32.0 mCi (1184 MBq).
Please see accompanying Brief Summary, including BOXED WARNINGS and additional safety information. Because the ZEVALIN
therapeutic regimen includes the use of rituximab, please also consult Prescribing Information for rituximab (www.rituxan.com).
© 2017 Spectrum Pharmaceuticals, Inc. All Rights Reserved. May not be reproduced, altered, or distributed without express permission. SPECTRUM PHARMACEUTICALS,
INC.® and ZEVALIN® are registered trademarks of Spectrum Pharmaceuticals, Inc. and its subsidiaries. The Spectrum Pharmaceuticals logo and ZEVALIN logo are trademarks
owned by Spectrum Pharmaceuticals, Inc. and its subsidiaries. RITUXAN® is a registered trademark of Biogen.
PP-ZEV-00-0120

ZEVALIN.com

Table of Contents for the Digital Edition of ASH News Daily 2017 - Issue 1