ASH Clinical News ACN_6.4s_SUPP_full_issue | Page 27

A treatment in R/R DLBCL
after at least 2 prior therapies
POLIVY in combination with bendamustine and a rituximab product is
the first and only regimen approved by the FDA based on a randomized
trial that studied patients with R/R DLBCL 1
NCCN GUIDELINES ®
RECOMMENDATION (CATEGORY 2A) 2
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) recommend polatuzumab vedotin-piiq (POLIVY) in
combination with bendamustine and rituximab (BR) as a treatment option, after at least 2 prior therapies, for patients
with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for transplant (Category 2A) 2 *
*See the NCCN Guidelines for detailed recommendations.
The National Comprehensive Cancer Network ® (NCCN ® ) makes no warranties of any kind whatsoever regarding their content,
use, or application and disclaims any responsibility for their application or use in any way.
R/R=relapsed/refractory; DLBCL=diffuse large B-cell lymphoma.
Granted FDA Breakthrough Therapy designation
Visit POLIVY.com/LearnMore for more information
Indication
POLIVY in combination with bendamustine and a rituximab
product is indicated for the treatment of adult patients with
relapsed or refractory diffuse large B-cell lymphoma (DLBCL),
not otherwise specified, after at least 2 prior therapies.
Accelerated approval was granted for this indication based on
complete response rate. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in a confirmatory trial.
Important Safety Information
Warnings and Precautions
Peripheral Neuropathy: Monitor patients for peripheral
neuropathy and modify or discontinue dose accordingly.
Infusion-Related Reactions: Premedicate with an antihistamine
and an antipyretic. Monitor patients closely during infusions.
Interrupt or discontinue infusion if reactions occur.
Myelosuppression: Monitor complete blood counts. Manage
using dose delays or reductions and growth factor support.
Monitor for signs of infection.
Serious and Opportunistic Infections: Closely monitor patients
for signs of bacterial, fungal, or viral infections.
Progressive Multifocal Leukoencephalopathy (PML): Monitor
patients for new or worsening neurological, cognitive, or
behavioral changes suggestive of PML.
Tumor Lysis Syndrome: Closely monitor patients with high
tumor burden or rapidly proliferating tumors.
Hepatotoxicity: Monitor liver enzymes and bilirubin.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of
reproductive potential of the potential risk to a fetus and to use
effective contraception during treatment and for 3 months after
the last dose.
The Most Common Adverse Reactions
The most common adverse reactions (≥20%) included neutropenia,
thrombocytopenia, anemia, peripheral neuropathy, fatigue,
diarrhea, pyrexia, decreased appetite, and pneumonia.
You may report side effects to the FDA at (800) FDA-1088 or
www.fda.gov/medwatch. You may also report side effects to
Genentech at [phone].
Please see brief summary of full Prescribing Information
for additional Important Safety Information.
References: 1. POLIVY Prescribing Information. South San Francisco, CA: Genentech, Inc.; June 2019. 2. Referenced with
permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for B-Cell Lymphomas V.5.2019.
© National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed September 23, 2019.
To view the most recent and complete version of the guideline, go online to NCCN.org.
© 2019 Genentech USA, Inc. All rights reserved. M-US-00000136(v1.0) 10/19