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DISCOVER EPKINLY
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Now approved for adults in 2L+ FL1
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EPKINLY + R2
is the first-and-only chemo-free,
bispecific antibody combination approved in R/R 2L+ FL
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Please see Important Safety Information, including Boxed Warnings for CRS and ICANS,
below.
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INDICATIONS
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EPKINLY is indicated in combination with lenalidomide and rituximab for
the treatment of adults with relapsed or refractory follicular lymphoma (FL). |
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EPKINLY is indicated as monotherapy for the treatment of adults with
relapsed or refractory FL after 2 or more lines of systemic therapy. |
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IMPORTANT SAFETY INFORMATION
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BOXED WARNINGS
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Cytokine release syndrome (CRS), including serious or fatal
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 2L follicular lymphoma (FL).1
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The EPCORE®
FL-1 study assessed PFS and ORR for EPKINLY in
combination with R2
vs
R2
alone in a phase 3, open-label, randomized,
multicenter, global trial in 488 patients with R/R FL after at least 1 line
of
systemic therapy.1,2
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| See how a broad range of
2L+ FL
patients responded to EPKINLY1
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| EPKINLY monotherapy is
also an
option for adults
with FL who have
received 2 or more previous lines
of therapy.1
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IMPORTANT SAFETY INFORMATION (continued)
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CRS
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CRS occurred in 49% (42/86) 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 48% of patients. Most events (88%) occurred during
Cycle 1. In Cycle 1, CRS events
occurred in 12% of patients after the 0.16 mg dose (Cycle 1, day 1), 6% after the
0.8 mg dose (Cycle 1, day 8), 15%
after the 3 mg dose (Cycle 1, day 15), and 37% after the first 48 mg dose (Cycle
1, day 22). The median time to onset of
CRS from the most recent administered dose across all doses was 59 hours (range:
0.1-7 days). The median time to onset
after the first full 48 mg dose was 61 hours (range: 0.1-7 days). |
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CRS occurred in 24% (32/131) of patients with FL receiving EPKINLY at the
recommended dosage schedule in combination
with lenalidomide and rituximab in the clinical trial (19% Grade 1, 5% Grade 2,
and 12% serious adverse reactions due to
CRS) and recurred in 41% of patients. Most events (88%) occurred during Cycle 1.
In Cycle 1, CRS occurred in 5% of
patients after the 0.16 mg dose (Cycle 1, day 1), 3.8% after the 0.8 mg dose
(Cycle 1, day 8), 2.3% after the 3 mg dose
(Cycle 1, day 15), and 18% after the first 48 mg dose (Cycle 1, day 22). The
median time to onset of CRS from the most
recent EPKINLY dose was 78 hours (range: 0.2 to 12 days). The median time to onset
after the first 48 mg dose was 41
hours (range: 0.3-12 days). |
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For patients with FL, assess whether hospitalization or outpatient monitoring for
the first 48 mg dose is appropriate
based on comorbidities or other situational factors. During outpatient monitoring
after the first 48 mg dose, patients
should remain in proximity to a healthcare facility that can assess and manage
CRS. |
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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 receiving EPKINLY
monotherapy, and 1.5% of patients receiving EPKINLY in combination with
lenalidomide and rituximab (reactions included
headache, confusional state, tremors, dizziness, and ataxia). |
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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, immediately evaluate patients for hospitalization, manage per
current practice guidelines, and
administer supportive care as appropriate. |
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ICANS
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ICANS occurred in 6% (8/127) of patients with FL receiving the 2-step up dosage
schedule in the clinical trial (3.9%
Grade 1, 2.4% Grade 2). The median time to onset was 22 days (range: 14-66 days)
from the start of treatment. Relative
to the most recent administered dose, the median time to onset of ICANS was 3 days
(range: 0.4-7 days). The median
duration of ICANS was 2 days (range: 1-7 days), with ICANS resolving in 100% of
patients. |
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Among patients with FL who received EPKINLY at the recommended dosage schedule in
combination with lenalidomide and
rituximab in the clinical trial, ICANS occurred in 0.8% (1/131, Grade 1). |
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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,
immediately evaluate patient, provide
supportive therapy based on severity, and manage per current practice guidelines.
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Infections
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EPKINLY can cause fatal and serious infections. Serious infections, including
opportunistic infections, were reported in
40% of patients with FL receiving EPKINLY monotherapy, following 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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Among 243 patients with FL who received EPKINLY in combination with lenalidomide
and rituximab in the clinical trial,
serious infections occurred in 28% of patients. The most common serious infections
were pneumonia (15%), COVID-19 (7%),
opportunistic infections (5%) and upper respiratory infections (3.3%). The most
common opportunistic infections of any
grade were CMV (cytomegalovirus) infection (7%) and herpesvirus infection (7%).
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Progressive multifocal leukoencephalopathy (PML), including fatal cases, has
occurred in patients treated with EPKINLY.
Across a broader clinical trial population, PML was reported in 0.4% (11/3072) of
patients, including in the first-line
treatment setting. Of the 11 cases of PML, 6 resulted in fatal outcomes and 1 was
unresolved at the time of death. |
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Monitor patients for signs and symptoms of infection and treat appropriately.
Avoid administration in patients with
active infections.
Withhold or consider permanent discontinuation of EPKINLY based on severity.
Provide Pneumocystis jirovecii pneumonia
(PJP) prophylaxis during treatment with EPKINLY, and consider prophylaxis against
herpesvirus. |
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Cytopenias
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EPKINLY can cause serious or severe cytopenias. In the clinical trial of patients
with FL who received EPKINLY
monotherapy following the 2-step up dosage schedule, Grade 3 or 4 decreased
neutrophils occurred in 30% (Grade 4, 17%),
decreased hemoglobin in 10% (Grade 4, 0%), and decreased platelets in 8% (Grade 4,
4%) of patients. Febrile neutropenia
occurred in 3.1% (Grade 4, 0%). |
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In patients with FL who received EPKINLY in combination with lenalidomide and
rituximab, Grade 3 or 4 decreased
neutrophils occurred in 67% (Grade 4, 41%), decreased lymphocytes in 62% (Grade 4,
13%), decreased hemoglobin in 7%, and
decreased platelets in 10% (Grade 4, 4.1%) of patients. Febrile neutropenia
occurred in 6% (Grade 4, 2.1%).
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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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EPKINLY as monotherapy for FL: Most common (≥20%) adverse reactions were CRS,
injection site reactions, fatigue,
musculoskeletal pain, fever, diarrhea, COVID-19, rash, and abdominal pain. Most
common Grade 3 to 4 laboratory
abnormalities (≥10%) were decreased lymphocytes, decreased neutrophils, decreased
hemoglobin, and decreased platelets. |
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EPKINLY in combination with lenalidomide and rituximab for FL: Most common (≥20%)
adverse reactions were rash, upper
respiratory tract infection, fatigue, injection site reactions, constipation,
diarrhea, CRS, pneumonia, COVID-19, and
fever. The most common Grade 3 to 4 laboratory abnormalities (≥10%) were decreased
neutrophils, decreased lymphocytes,
and decreased platelets. |
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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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2L=second line; 3L=third line; FL=follicular lymphoma; ORR=overall response rate;
PFS=progression-free survival; R2=rituximab +
lenalidomide;
R/R=relapsed/refractory.
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References: 1. EPKINLY [package
insert]. Plainsboro, NJ: Genmab US, Inc. and North Chicago, IL: AbbVie Inc. 2025.
2. Clinicaltrials.gov. Study of subcutaneous epcoritamab in combination
with intravenous
rituximab and oral lenalidomide
(R2) to assess adverse events and change in disease activity in adult participants
with follicular lymphoma (EPCORE
FL-1).
Updated July 28, 2025. Accessed September 15, 2025.
https://clinicaltrials.gov/study/NCT06191744
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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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©2025 Genmab A/S and AbbVie. All rights reserved.
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11/2025 COM-US-EPK-0001790
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