AbbVie Announces TEPKINLY® (epcoritamab) in Combination with Lenalidomide and Rituximab is Approved by the European Commission for the Treatment of Relapsed or Refractory Follicular Lymphoma

• TEPKINLY^® (epcoritamab) plus lenalidomide and rituximab (R²) is the first and only bispecific-based therapy approved in Europe for the treatment of relapsed or refractory follicular lymphoma in the second-line setting, offering a chemotherapy-free option
• In the Phase 3 EPCORE^® FL-1 trial, fixed-duration TEPKINLY + R² achieved statistically significant improvement of progression-free survival and overall response rates compared to R², with approximately three out of four patients achieving a complete response

NORTH CHICAGO, Ill., July 6, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that the European Commission (EC) granted marketing authorization for TEPKINLY^® (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R²) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE^® FL-1 trial, which evaluated fixed-duration TEPKINLY in combination with R² compared to standard of care R².

"Follicular lymphoma is a persistent form of cancer that remains incurable, which means patients need more treatment options. Patients often relapse and experience shorter remissions and have fewer treatment options each time the disease returns," said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris Cité University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. "The results shown in the EPCORE FL-1 trial are clinically meaningful, demonstrating the potential for TEPKINLY + R² to change the treatment paradigm for patients, offering the chance at a durable response with a chemotherapy-free option."

The marketing authorization is supported by data from the Phase 3 EPCORE FL-1 trial, an open-label interventional trial to evaluate the safety and efficacy of TEPKINLY + R² compared to R² alone in patients with R/R FL. The study demonstrated TEPKINLY + R² reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.13 - 0.33, p<0.0001) compared to R² alone. The overall response rate (ORR) in patients treated with TEPKINLY + R² was 96% (95% CI: 90.2, 98.6) compared to 81% in patients treated with R² (95% CI: 72.7, 87.7; p<.0001). Among patients who were treated with TEPKINLY + R², 74% achieved a complete response (CR) (n=181/243, 95% CI: 68.5, 79.8) compared to a 43% CR rate among patients treated with R² (n=106/245, 95% CI: 37.0, 49.7).

The safety profile of TEPKINLY + R² in the EPCORE FL-1 study was consistent with the known safety profiles of the individual regimens (epcoritamab and R²). In the trial, the most common (≥ 20%) adverse reactions were neutropenia, rash, upper respiratory tract infections, fatigue, diarrhea, injection site reactions, anemia, constipation, thrombocytopenia, cytokine release syndrome (CRS), hypogammaglobulinemia, COVID-19, pyrexia, and pneumonia. Serious adverse reactions occurred in 44% of patients who received epcoritamab in combination with lenalidomide and rituximab. Serious adverse reactions in ≥ 5% of patients included CRS, pneumonia, COVID-19, and febrile neutropenia.

"There remains a critical need for new treatment options to improve outcomes for patients with relapsed or refractory follicular lymphoma, particularly in earlier lines of therapy," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "This approval is important because it brings an effective treatment option to patients across Europe, representing meaningful progress for patients with follicular lymphoma." 

FL is typically a slow-growing form of non-Hodgkin lymphoma (NHL) that arises from B-cell lymphocytes. FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases.¹ FL incidence is significantly higher in European populations, 11-29 percent, compared to non-European populations, 2-18 percent.² FL is considered incurable, and there is no standard of care treatment for third-line or later FL.^1,3 Patients who achieve remission also often experience relapse.^4,5,6

"A diagnosis of follicular lymphoma can bring a relentless cycle of disease recurrence and treatment," said Mitchell Smith, M.D., Ph.D., Chief Medical Officer of the Follicular Lymphoma Foundation. "The approval of epcoritamab now in combination with R² in Europe is a welcome advance that will bring an innovative treatment option and hope to the follicular lymphoma community."

About the EPCORE^® FL-1 Trial 

EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus lenalidomide and rituximab (R²) versus R² alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The Phase 3 EPCORE FL-1 study included patients with relapsed or recurrent FL following at least one prior line of treatment across a broad range of patient characteristics and disease risk factors. Patients were randomized to receive epcoritamab in combination with R² (n=243) or R² alone (n=245). Patients received epcoritamab in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR). The pivotal Phase 3 EPCORE FL-1 trial results were published in The Lancet in January 2026.

About Epcoritamab

Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody^® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.⁶

Epcoritamab (approved under the brand name EPKINLY^® in the U.S. and Japan, and TEPKINLY^® in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 territories. Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (DLBCL) indication. 

AbbVie and Genmab continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R²) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

EU Indications and Important Safety Information about Tepkinly^® ▼ (epcoritamab)

Indications

Tepkinly (epcoritamab) as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Important Safety Information

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

Cytokine release syndrome (CRS)

CRS, which may be life-threatening or fatal, occurred in patients receiving Tepkinly. The most common signs and symptoms of CRS include pyrexia, hypotension and hypoxia. Other signs and symptoms of CRS in more than two patients include chills, tachycardia, headache and dyspnoea.

Most CRS events occurred in Cycle 1 and were associated with the first full dose of Tepkinly. Administer prophylactic corticosteroids to mitigate the risk of CRS. Patients should be monitored for signs and symptoms of CRS following Tepkinly administration. At the first signs or symptoms of CRS, institute treatment of supportive care with tocilizumab and/or corticosteroids as appropriate. Patients should be counselled on the signs and symptoms associated with CRS and patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time. Management of CRS may require either temporary delay or discontinuation of Tepkinly based on the severity of CRS.

Haemophagocytic lymphohistiocytosis (HLH)

Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, have been reported in patients receiving Tepkinly. HLH is a life-threatening syndrome characterised by fever, skin rash, lymphadenopathy, hepato- and/or splenomegaly and cytopenias. HLH should be considered when the presentation of CRS is atypical or prolonged. Patients should be monitored for clinical signs and symptoms of HLH. For suspected HLH, Tepkinly must be interrupted for diagnostic workup and treatment for HLH initiated. If HLH is confirmed, administration of Tepkinly should be discontinued.

Immune effector cell-associated neurotoxicity syndrome (ICANS)

ICANS, including fatal events, have occurred in patients receiving Tepkinly. ICANS may manifest as aphasia, altered level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral oedema. The majority of cases of ICANS occurred within Cycle 1 of Tepkinly treatment, however some occurred with delayed onset. Patients should be monitored for signs and symptoms of ICANS following Tepkinly administration. At the first signs or symptoms of ICANS treatment with corticosteroids and non-sedating-anti-seizure medicinal products should be instituted as appropriate. Patients should be counselled on the signs and symptoms of ICANS and that the onset of events may be delayed. Patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time. Tepkinly should be delayed or discontinued as recommended.

Serious infections

Treatment with Tepkinly may lead to an increased risk of infections. Serious or fatal infections were observed in patients treated with Tepkinly in clinical studies. Administration of Tepkinly should be avoided in patients with clinically significant active systemic infections. As appropriate, prophylactic antimicrobials should be administered prior to and during treatment with Tepkinly. Patients should be monitored for signs and symptoms of infection, before and after Tepkinly administration, and treated appropriately. In the event of febrile neutropenia, patients should be evaluated for infection and managed with antibiotics, fluids and other supportive care, according to local guidelines.

Hypogammaglobulinaemia has also been reported in patients receiving Tepkinly. Immunoglobulin (Ig) levels should be monitored prior to and during treatment. Patients should be treated according to local institutional guidelines, including infection precautions and antimicrobial prophylaxis.

Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported in patients treated with Tepkinly who have also received prior treatment with other immunosuppressive medications. If neurological symptoms suggestive of PML occur during Tepkinly therapy, treatment with Tepkinly should be discontinued and appropriate diagnostic measures initiated.

Tumour Lysis Syndrome (TLS)

TLS has been reported in patients receiving Tepkinly. Patients at an increased risk for TLS are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent. Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function. Patients should be monitored for blood chemistries and abnormalities should be managed promptly.

Tumour flare

Tumour flare has been reported in patients treated with Tepkinly. Manifestations could include localized pain and swelling. Consistent with the mechanism of action of Tepkinly, tumour flare is likely due to the influx of T-cells into tumour sites following Tepkinly administration. There are no specific risk factors for tumour flare that have been identified; however, there is a heightened risk of compromise and morbidity due to mass effect secondary to tumour flare in patients with bulky tumours located in close proximity to airways and/or a vital organ. Patients treated with Tepkinly should be monitored and evaluated for tumour flare at critical anatomical sites.

CD20-negative disease

There are limited data available on patients with CD20-negative DLBCL and patients with CD20-negative FL treated with Tepkinly, and it is possible that patients with CD20-negative DLBCL and CD20-negative FL may have less benefit compared to patients with CD20-positive DLBCL and patients with CD20-positive FL, respectively. The potential risks and benefits associated with treatment of patients with CD20-negative DLBCL and FL with Tepkinly should be considered.

Immunisation

Live and/or live-attenuated vaccines should not be given during Tepkinly therapy. Studies have not been conducted in patients who received live vaccines.

Fertility, pregnancy and lactation

Tepkinly is not recommended during pregnancy, while breast-feeding, and in women of childbearing potential not using contraception.

Effects on ability to drive and use machines

Tepkinly has a major influence on the ability to drive and use machines. Due to the potential for ICANS, patients receiving Tepkinly are at risk of altered level of consciousness. Patients should be advised to exercise caution while (or avoid if symptomatic) driving, cycling or using heavy or potentially dangerous machines.

Undesirable effects

Summary of the safety profile

Tepkinly Monotherapy

The safety of Tepkinly was evaluated in 382 patients with relapsed or refractory large B-cell lymphoma (N=167), FL (N=129) and FL (3-step step-up dose schedule N=86) after two or more lines of systemic therapy and included all the patients who enrolled to the 48 mg dose and received at least one dose of TEPKINLY. The most common adverse reactions (≥ 20%) were CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia, and diarrhoea.

Serious adverse reactions occurred in 50% of patients. The most frequent serious adverse reaction (≥ 10%) was cytokine release syndrome (34%). Fourteen patients (3.7%) experienced a fatal adverse reaction (pneumonia in 9 (2.4%) patients, viral infection in 4 (1.0%) patients, and ICANS in 1 (0.3%) patient). Adverse reactions that led to discontinuation occurred in 6.8% of patients. Discontinuation of Tepkinly due to pneumonia occurred in 14 (3.7%) patients, viral infection in 8 (2.1%) patients, fatigue in 2 (0.5%) patients, and CRS, ICANS, or diarrhoea, in 1 (0.3%) patient each.

Dose delays due to adverse reactions occurred in 42% of patients. Adverse reactions leading to dose delays (≥ 3%) were viral infections (17%), CRS (11%), neutropenia (5.2%), pneumonia (4.7%), upper respiratory tract infection (4.2%), and pyrexia (3.7%).

Tepkinly in combination with lenalidomide and rituximab

The safety of Tepkinly in combination with lenalidomide and rituximab was evaluated in 243 patients with relapsed or refractory follicular lymphoma (FL) after one prior line of therapy (3-step step-up dose schedule N=133). The most common (≥ 20%) adverse reactions were neutropenia, rash, upper respiratory tract infections, fatigue, diarrhoea, injection site reactions, anaemia, constipation, thrombocytopenia, CRS, hypogammaglobulinaemia, COVID-19, pyrexia, and pneumonia.

Serious adverse reactions occurred in 44% of patients. Serious adverse reactions in ≥ 5% of patients included CRS, pneumonia, COVID-19, and febrile neutropenia. Adverse reactions that led to permanent discontinuation of Tepkinly occurred in 6.6% of patients. Discontinuation of Tepkinly in more than 1 patient included pneumonia, COVID-19, upper respiratory tract infections, and neutropenia.

Dose delays due to an adverse reaction occurred in 70% of patients. Adverse reactions which resulted in dose delays (≥ 5%) included neutropenia, upper respiratory tract infections, COVID-19, pneumonia, rash, and thrombocytopenia.

This is not a complete summary of all safety information. 

See Tepkinly^® full Summary of Product Characteristics (SmPC) at www.ema.europa.eu

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Oncology

AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.

Today, our expansive oncology portfolio is comprised of approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 35 investigational medicines across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit us at http://www.abbvie.com/oncology.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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