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Developed under the direction and sponsorship of Genmab US, Inc. and AbbVie Inc. |
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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 | | |  |
