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DISCOVER EPKINLY
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Now approved for adults in 3L+ FL1
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EPKINLY is the first-and-only subcutaneous bispecific antibody in FL
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Granted accelerated approval based on response rate and durability of response.
Continued approval for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory trial(s).1
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Please see Important Safety Information, including Boxed Warnings for CRS and ICANS,
below.
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INDICATION
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EPKINLY is indicated for the treatment of adults with relapsed or refractory
follicular lymphoma (FL) after 2 or more lines of systemic therapy.
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This indication is approved under accelerated approval based on response rate and
durability of response. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory trial(s).
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IMPORTANT SAFETY INFORMATION
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BOXED WARNINGS
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Cytokine release syndrome (CRS), including serious or life-threatening reactions,
can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY
step-up dosage schedule to reduce the incidence and severity of CRS. Withhold
EPKINLY until CRS resolves or permanently discontinue based on severity. |
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Immune effector cell–associated neurotoxicity syndrome (ICANS), including
life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for
neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until
ICANS resolves or permanently discontinue based on severity. |
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Please see additional Important Safety Information below.
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Genmab and AbbVie are pleased to share that EPKINLY is now FDA approved
for adults with 3L+ follicular lymphoma (FL).1
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EPKINLY is an innovatively designed T-cell engaging bispecific antibody
developed using Genmab's innovative DuoBody®
platform. EPKINLY binds to T cells through CD3 and lymphoma and healthy
B-lineage cells through CD20. In vitro, EPKINLY was shown to induce
T-cell–mediated lysis of CD20-expressing B cells.1,2
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NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®)
Recommended |
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The NCCN Guidelines®
recommend epcoritamab-bysp (EPKINLY) as an NCCN Category 2A
preferred treatment option after 2 or more lines of systemic
therapy for patients with relapsed or refractory
follicular lymphoma.3*
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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.
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* |
See NCCN Guidelines for the NCCN definitions of Categories of
Preference and Categories of Evidence and Consensus. |
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| See how
challenging-to-treat 3L+ FL patients responded to
EPKINLY |
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IMPORTANT SAFETY INFORMATION (continued)
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CRS
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CRS occurred in 49% of patients with FL receiving the recommended 3-step up dosage
schedule in the clinical trial (45% grade 1, 9% grade 2) and recurred in 23% of
patients. Most events (88%) occurred during cycle 1, with 49% occurring after the
48 mg dose on cycle 1, day 22. |
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In patients who experienced CRS, the signs and symptoms included pyrexia,
hypotension, hypoxia, dyspnea, chills, and tachycardia. Concurrent neurological
adverse reactions associated with CRS occurred in 4.7% of patients with FL and
included headache and dizziness. |
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Administer pretreatment medications to reduce the risk of CRS. Monitor patients
for potential CRS. At the first signs or symptoms of CRS, manage per current
practice guidelines and administer supportive care as appropriate. |
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ICANS
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ICANS occurred in 6% of patients with FL receiving the 2-step up dosage schedule
in the clinical trial (3.9% grade 1, 2.4% grade 2). |
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The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in
the absence of CRS. Clinical manifestations of ICANS included, but were not
limited to, confusional state, lethargy, tremor, dysgraphia, aphasia, and
non-convulsive status epilepticus. |
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Monitor patients for potential ICANS. At the first signs or symptoms of ICANS,
manage per current practice guidelines and administer supportive care as
appropriate. |
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Infections
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EPKINLY can cause serious and fatal infections. Serious infections, including
opportunistic infections were reported in 40% of patients with FL receiving the
2-step up dosage schedule in the clinical trial (most common: 20% COVID-19, 13%
pneumonia, 3% urinary tract infections). Fatal infections occurred in 6% of
patients (5% COVID-19, 0.8% pneumonia, 0.8% sepsis). |
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Monitor patients for signs and symptoms of infection prior to and during treatment
and treat appropriately. Avoid administration in patients with active infections.
Withhold or consider permanent discontinuation of EPKINLY based on severity. Prior
to starting EPKINLY, provide Pneumocystis jirovecii pneumonia (PJP)
prophylaxis and consider prophylaxis against herpes virus. |
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Cytopenias
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EPKINLY can cause serious or severe cytopenias. In the clinical trial of patients
with FL receiving the 2-step up dosage schedule, grade 3 or 4 events occurred in
30% (neutrophils decreased), 10% (hemoglobin decreased), and 8% (platelets
decreased). Febrile neutropenia occurred in 3.1%. |
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Monitor complete blood counts throughout treatment. Based on severity of
cytopenias, temporarily withhold or permanently discontinue EPKINLY. Consider
prophylactic granulocyte colony-stimulating factor administration as applicable.
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Embryo-Fetal Toxicity
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EPKINLY may cause fetal harm when administered to a pregnant woman. Advise females
of reproductive potential to use effective contraception during treatment with
EPKINLY and for 4 months after the last dose. Verify pregnancy status in females
of reproductive potential prior to initiating EPKINLY. |
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Adverse Reactions
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Most common (≥20%) adverse reactions were injection site reactions, CRS,
COVID-19, fatigue, upper respiratory tract infection, musculoskeletal pain, rash,
diarrhea, pyrexia, cough, and headache. The most common grade 3 to 4 laboratory
abnormalities (≥10%) were decreased lymphocytes, decreased neutrophils,
decreased white blood cells, and decreased hemoglobin. |
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Use in Specific Populations
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Lactation: Advise women not to breastfeed during treatment and
for 4 months after the last dose of EPKINLY.
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Geriatric Use: In patients with relapsed or refractory FL who
received EPKINLY in the clinical trial, 52% were ≥65 years old, and 13% were
≥75 years old. A higher rate of fatal adverse reactions, primarily infections,
including COVID-19, was observed in patients ≥65 years old compared to younger
adult patients. No overall difference in efficacy was observed.
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3L=third line; CD3=cluster of differentiation 3; CD20=cluster of differentiation 20;
NCCN=National Comprehensive Cancer Network.
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References: 1. EPKINLY [package
insert]. Plainsboro, NJ: Genmab US, Inc. and North Chicago, IL: AbbVie Inc. 2024.
2. Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces
potent T-cell-mediated killing of malignant B cells in preclinical models and provides
opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625.
doi:10.1016/j.ebiom.2019.102625 3. Referenced with permission
from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
for B-Cell lymphoma. V.2.2024. © National Comprehensive Cancer Network, Inc.
2024. All rights reserved. Accessed April 30, 2024. To view the most recent and
complete version of the guidelines, go online to NCCN.org.
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This email is intended for US healthcare professionals only. Please do not reply.
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This commercial email is brought to you by Genmab US, Inc. and AbbVie Inc.
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Distributed and marketed by Genmab US, Inc., 777 Scudders Mill Road,
Plainsboro, NJ 08536.
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Distributed and marketed by AbbVie Inc., 1 North Waukegan Road, North
Chicago, IL 60064.
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EPKINLY is a trademark of Genmab A/S.
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©2024 Genmab A/S and AbbVie. All rights reserved.
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6/2024 COM-US-EPK-0000622
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