Tepkinly
Authorised
This medicine is authorised for use in the European Union
epcoritamab
MedicineHumanAuthorised
Lithuanian is available via eTranslation, the European Commission's machine translation service.
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Tepkinly is a cancer medicine used to treat adults with:
diffuse large B-cell lymphoma (DLBCL) when the cancer has returned (relapsed) or stopped responding to treatment (refractory) after at least two previous treatments;
follicular lymphoma (FL) when the cancer has returned or stopped responding to treatment after at least two previous treatments;
follicular lymphoma (FL), in combination with lenalidomide and rituximab (other medicines), when the cancer has returned or stopped responding to treatment.
Tepkinly contains the active substance epcoritamab.
Tepkinly can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in treating cancer, with access to tocilizumab, a medicine to manage a potentially severe side effect called cytokine release syndrome (CRS, a potentially life-threatening condition that causes fever, vomiting, shortness of breath, headache and low blood pressure).
Tepkinly is given as an injection under the skin, in cycles of 28 days. For all patients, treatment starts with weekly injections from cycle 1 to 3.
When Tepkinly is used for DLBCL or FL in patients whose cancer has returned or stopped responding to treatment after at least two previous treatments, dosing is reduced to one injection every 2 weeks from cycle 4 to 9 and then one injection every 4 weeks from cycle 10 onward. Treatment can continue until the disease gets worse or unacceptable side effects occur.
When Tepkinly is used in combination with lenalidomide and rituximab for FL, dosing is reduced to one injection every 4 weeks from cycle 4 to 12. Tepkinly is given with lenalidomide for up to 12 cycles, and patients also receive rituximab for the first 5 cycles. Treatment lasts a maximum of 12 cycles unless the disease gets worse or unacceptable side effects occur.
Treatment with Tepkinly may be temporarily or permanently stopped if certain side effects occur.
Before an injection of Tepkinly, patients need to be well hydrated and take other medicines to reduce the risk of certain side effects. They should also be monitored for side effects like CRS and immune effector cell-associated neurotoxicity syndrome (ICANS), a neurological disorder with symptoms including problems with speech and writing, confusion and altered consciousness.
For more information about using Tepkinly, see the package leaflet or contact your doctor or pharmacist.
DLBCL and FL are cancers that affect B cells, a type of white blood cell. The active substance in Tepkinly, epcoritamab, is an antibody (a type of protein) that is described as bispecific because it recognises and attaches to two targets simultaneously: CD20, a protein that is present on the surface of B cells (including the cancer cells), and CD3, a protein found on the surface of healthy T cells (cells in the immune system). By attaching to CD20 and CD3 proteins, Tepkinly brings the cancer cells and T cells together. This encourages the T cells to destroy the cancer cells and helps control the disease.
The benefits of Tepkinly were evaluated in a main study involving adults with DLBCL or FL whose cancer had returned or was not responding after at least two other treatments. In this study, Tepkinly was given for an average of four months and was not compared with other medicines or placebo (dummy treatment). Of the patients with DLBCL, 62% (86 out of 139) had either a complete response (no sign of cancer) or a partial response (shrinking of the cancer) to Tepkinly; they maintained these responses for an average of around 16 months. Of the patients with FL, about 83% (106 out of 128) had either a complete or partial response to Tepkinly; they maintained these responses for an average of around 21 months.
A second main study involved 549 adults with FL whose cancer had returned or had not responded to previous treatment. Participants were given lenalidomide and rituximab with or without Tepkinly. The main measure of effectiveness was progression-free survival (PFS), the length of time patients lived without their disease getting worse. Tepkinly improved PFS.
After patients were followed for an average of 10 months, patients treated with lenalidomide and rituximab alone lived for a median time of 11 months without their disease getting worse. This time could not be calculated for patients also given Tepkinly because not enough people had experienced worsening of their disease. Around 9% of patients given Tepkinly, lenalidomide and rituximab died or had their disease get worse, compared with around 31% of patients given lenalidomide and rituximab only.
Additionally, the length of time patients lived overall could not be calculated because this was too early in the study to do so.
Studies carried out with Tepkinly are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions with Tepkinly, see the package leaflet.
When used on its own for the treatment of DLBCL or FL, the most common side effects with Tepkinly (which may affect more than 1 in 5 people) include CRS, tiredness, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), injection site reactions, viral infections, pain in muscles and bones, fever and diarrhoea. Some side effects can be serious. The most frequent (which may affect more than 3 in 10 people) is CRS.
When used in combination with lenalidomide and rituximab for the treatment of FL, the most common side effects with Tepkinly (which may affect more than 1 in 5 people) include neutropenia, rash, upper respiratory tract infections (nose and throat infections), tiredness, diarrhoea, injection site reactions, anaemia (low levels of red blood cells), constipation, thrombocytopenia (low levels of blood platelets), CRS, hypogammaglobulinaemia (low levels of antibodies), COVID-19, fever and pneumonia (infection of the lungs). The most frequent serious side effects (which may affect more than 1 in 20 people) include CRS, pneumonia, COVID-19 and febrile neutropenia (low levels of white blood cells with fever).
Patients with DLBCL and FL whose cancer has returned or not responded after at least two previous treatments have limited treatment options. Treatment with Tepkinly was shown to provide a clinically meaningful and durable response.
Tepkinly, when used in combination with lenalidomide and rituximab, was shown to delay disease progression in patients with FL whose cancer has returned or not responded to previous treatment
Although serious side effects, particularly CRS and ICANS, can occur, they were considered manageable with the measures in place. The European Medicines Agency therefore decided that Tepkinly’s benefits are greater than its risks and it can be authorised for use in the EU.
Tepkinly has been given conditional authorisation for use in the EU. This means that it has been authorised on the basis of less comprehensive data than are normally required because it fulfills an unmet medical need. The Agency considers that the benefit of having the medicine available earlier outweighs any risks associated with using it while awaiting further evidence.
The company for Tepkinly must provide further data on the medicine. To confirm the safety and efficacy of Tepkinly in patients with relapsed or refractory DLBCL or FL, the company must submit the results from 3 studies. Every year, the Agency will review any new information that becomes available.
The company that markets Tepkinly will provide patients with an alert card to inform them about the risks of the serious side effects CRS and ICANS. It will also include instructions on when to contact their doctor if they experience symptoms.
In addition, the company will provide the final results of a study with Tepkinly to confirm the safety and effectiveness of the recommended dose.
Should we add this sentence? These materials may be made available by national competent authorities on their websites. A list of national repositories is available on the EMA website.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tepkinly have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Tepkinly are continuously monitored. Suspected side effects reported with Tepkinly are carefully evaluated and any necessary action taken to protect patients.
Tepkinly received a conditional marketing authorisation valid throughout the EU on 22 September 2023.
Product information
Latest procedure affecting product information:VR/0000311043
02/07/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Tepkinly
- Active substance
- epcoritamab
- International non-proprietary name (INN) or common name
- epcoritamab
- Therapeutic area (MeSH)
- Lymphoma, Large B-Cell, Diffuse
- Anatomical therapeutic chemical (ATC) code
- L01FX27
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Tepkinly 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.
Assessment history
News on Tepkinly
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