Tepkinly

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Authorised

This medicine is authorised for use in the European Union

epcoritamab
MedicineHumanAuthorised
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

Tepkinly is a cancer medicine used to treat adults with blood cancers called diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), in patients whose cancer has returned (relapsed) or stopped responding (refractory) after at least two previous treatments.

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, in a location with appropriate medical support to manage severe side effects such as 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. Treatment starts with weekly injections from cycle 1 to 3, followed by an injection every 2 weeks from cycle 4 to 9. From cycle 10 onward, the medicine is given every 4 weeks. Treatment can continue until the disease gets worse or unacceptable side effects occur.

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, especially after receiving the full dose for the first time.

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) which 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 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.

For the full list of side effects and restrictions with Tepkinly, see the package leaflet.

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 infection, pain in muscles and bones, fever and diarrhoea. The most common serious side effect (which may affect more than 3 in 10 people) was CRS. 

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. Although serious side effects, particularly CRS and ICANS, can occur, they were considered manageable with appropriate measures. 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’. 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 must provide further data on Tepkinly. To confirm the safety and efficacy of Tepkinly in patients with relapsed or refractory DLBCL or FL, the company that markets the medicine 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. The company will provide the final results of a study with Tepkinly to confirm the safety and effectiveness of the recommended dose.

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.

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Product information

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Latest procedure affecting product information: IB/0006
25/10/2024
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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).

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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 agents

Therapeutic 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 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.

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 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. 

Authorisation details

EMA product number
EMEA/H/C/005985

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG

Knollstrasse
67061 Ludwigshafen
Germany

Opinion adopted
20/07/2023
Marketing authorisation issued
22/09/2023
Revision
3

Assessment history

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