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.