POLIVY + bendamustine + a rituximab product (BR)
Advance the possibilities in R/R DLBCL,
NOS, after at least 2 prior therapies 1
Granted accelerated approval. Additional studies are needed to establish clinical benefi t.
NCCN GUIDELINES ® PREFERRED TREATMENT (CATEGORY 2A) 2
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) recommend polatuzumab vedotin-piiq (POLIVY)
+ bendamustine + rituximab (BR) as a preferred 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 or refractory; DLBCL=diffuse large B-cell lymphoma; NOS=not otherwise specifi ed.
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
specifi ed, 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 verifi cation and description of clinical
benefi t in a confi rmatory trial.
Important Safety Information
Peripheral Neuropathy
POLIVY can cause peripheral neuropathy, including severe cases.
Peripheral neuropathy occurs as early as the fi rst cycle of
treatment and is cumulative. POLIVY may exacerbate preexisting
peripheral neuropathy.
In Study GO29365, of 173 patients treated with POLIVY, 40%
reported new or worsening peripheral neuropathy, with a
median time to onset of 2.1 months.
Monitor for symptoms of peripheral neuropathy. Patients
experiencing new or worsening peripheral neuropathy may
require a delay, dose reduction, or discontinuation of POLIVY.
Infusion-Related Reactions
POLIVY can cause infusion-related reactions, including severe
cases. Delayed infusion-related reactions as late as 24 hours after
receiving POLIVY have occurred. With premedication, 7% of patients
(12/173) in Study GO29365 reported infusion-related reactions after
administration of POLIVY.
Administer an antihistamine and an antipyretic prior to the
administration of POLIVY, and monitor patients closely throughout
the infusion. If an infusion-related reaction occurs, slow or interrupt
the infusion and institute appropriate medical management.
Myelosuppression
Treatment with POLIVY can cause serious or severe
myelosuppression, including neutropenia, thrombocytopenia, and
anemia. In patients treated with POLIVY plus bendamustine and a
rituximab product (BR) (n=45), 42% received primary prophylaxis
with granulocyte colony-stimulating factor. Cytopenias were the most
common reason for treatment discontinuation (18% of all patients).
Monitor complete blood counts throughout treatment. Cytopenias
may require a delay, dose reduction, or discontinuation of POLIVY.
Consider prophylactic granulocyte colony-stimulating factor
administration.
Serious and Opportunistic Infections
Fatal and/or serious infections, including opportunistic infections such
as sepsis, pneumonia (including Pneumocystis jiroveci and other
fungal pneumonia), herpesvirus infection, and cytomegalovirus
infection have occurred in patients treated with POLIVY. Grade 3 or
higher infections occurred in 32% (55/173) of patients treated with
POLIVY. Infection-related deaths were reported in 2.9% of patients
within 90 days of last treatment.
Closely monitor patients during treatment for signs of infection.
Administer prophylaxis for Pneumocystis jiroveci pneumonia
and herpesvirus.
Progressive Multifocal Leukoencephalopathy (PML)
PML has been reported after treatment with POLIVY (0.6%, 1/173).
Monitor for new or worsening neurological, cognitive, or behavioral
changes. Hold POLIVY and any concomitant chemotherapy if PML is
suspected, and permanently discontinue if the diagnosis is confirmed.
Tumor Lysis Syndrome (TLS)
POLIVY may cause TLS. Patients with high tumor burden and rapidly
proliferating tumors may be at increased risk of TLS. Monitor
closely and take appropriate measures, including TLS prophylaxis.