Tecvayli
Authorised
This medicine is authorised for use in the European Union
teclistamab
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Tecvayli is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow) that has come back or not responded to previous treatment. It can be used:
on its own in adults who have received at least three previous treatments for their cancer, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment;
in combination with daratumumab (another cancer medicine) in adults whose cancer has worsened after at least one previous treatment.
Tecvayli contains the active substance teclistamab.
Tecvayli can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma. It must be given in a facility with appropriate medical support to manage severe side effects such as cytokine release syndrome (a potentially life-threatening condition that causes fever, vomiting, shortness of breath, headache and low blood-pressure).
Tecvayli is given as an injection under the skin. The recommended dose is based on the patient’s body weight. When used on its own, treatment starts with injections on days 1, 3 and 5 at increasing doses (so-called step-up dosing). This is then followed by an injection given once-weekly. For patients using Tecvayli on its own and whose cancer has responded very well to treatment for at least 6 months, the doctor may consider giving Tecvayli once every 2 weeks instead.
When used in combination with daratumumab, only daratumumab is given on day 1. Treatment with Tecvayli starts with a step-up dosing schedule: injections of Tecvayli are given at increasing doses on days 2, 4 and 8. A maintenance dose is then given once weekly from weeks 3 to 8, every 2 weeks from weeks 9 to 24 and every 4 weeks from week 25 onwards.
One to three hours before receiving the injections that are given as part of the step-up dosing schedule, patients are given medicines to reduce the risk of developing cytokine release syndrome. Treatment can continue until the disease gets worse or the patient experiences unacceptable side effects.
For more information about using Tecvayli, see the package leaflet or contact your doctor or pharmacist.
The active substance in Tecvayli is teclistamab, an antibody (a type of protein) that is designed to recognise and attach to two targets simultaneously: the B cell maturation antigen (BCMA) on myeloma cells and CD3 on the surface of T cells (cells in the immune system). By attaching to these target proteins, this medicine brings the cancer cells and T cells together. This activates the T cells, which then kill the multiple myeloma cells.
The benefits of Tecvayli have been investigated in an ongoing study involving 165 patients with multiple myeloma who had received at least three prior treatments (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody) and whose disease had not improved (refractory) or had come back (relapsed) after the last treatment. The study did not compare Tecvayli with other medicines or placebo (a dummy treatment). In this study, 63% (104 out of 165) of patients responded to treatment with Tecvayli and they lived for an average of 18 months without their disease getting worse.
Another main study involved 587 adults with multiple myeloma whose cancer had worsened after at least one previous treatment (including a proteasome inhibitor and lenalidomide, a type of immunomodulatory agent). The study compared Tecvayli given together with daratumumab with daratumumab given with either bortezomib or pomalidomide (other cancer medicines) and dexamethasone. The main measure of effectiveness was how long patients lived without their cancer getting worse. Based on the available data, after 36 months of treatment, around 83% of patients who received treatment with Tecvayli and daratumumab were alive without their disease getting worse compared with around 30% of patients who received daratumumab given with either bortezomib or pomalidomide and dexamethasone. In addition, after 36 months of treatment around 83% of those who received treatment with Tecvayli and daratumumab were alive compared with around 65% of those who received daratumumab given with either bortezomib or pomalidomide and dexamethasone.
Studies carried out with Tecvayli are described in more detail in the medicines assessment reports.
For the full list of side effects and restrictions of Tecvayli, see the package leaflet.
The most common side effects with Tecvayli (which may affect more than 1 in 10 people) include hypogammaglobulinaemia (low immunoglobulin or antibody levels in the blood, which increases the risk of infection), cytokine release syndrome, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), anaemia (low levels of red blood cells or haemoglobin), pain in the muscles and bones, tiredness, thrombocytopenia (low levels of blood platelets, components that help the blood to clot), injection site reactions, upper respiratory tract (nose and throat) infection, lymphopenia (low levels of lymphocytes, a type of white blood cell), diarrhoea, pneumonia (infection of the lungs), COVID-19, nausea (feeling sick), fever, headache, cough, pain and hypokalaemia (low blood potassium levels).
Some side effects can be serious. The most frequent (which may affect more than 1 in 10 people) include pneumonia, COVID-19 and cytokine release syndrome. Upper respiratory tract infection, sepsis (blood poisoning; when bacteria and their toxins circulate in the blood, leading to organ damage), fever, pain in the muscles and bones, diarrhoea and febrile neutropenia (low levels of neutrophils with fever) may affect up to 1 in 10 people.
At the time of approval, treatment options were limited for patients with multiple myeloma once they no longer respond to an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Tecvayli addressed a medical need in these patients and showed a clinically relevant treatment effect.
Compared with other daratumumab-based treatments, Tecvayli used with daratumumab helped patients live longer without their multiple myeloma getting worse and also increased how long patients lived overall. The daratumumab-based treatments used for comparison in the study were daratumumab with bortezomib and dexamethasone or daratumumab with pomalidomide and dexamethasone. Tecvayli and daratumumab work in different ways to target the cancer; using them together provided a meaningful benefit for patients whose disease had come back or no longer responded to previous treatment.
Tecvayli was originally given ‘conditional authorisation’. The authorisation was then switched to standard authorisation as the company had provided additional data requested by the Agency.
Since Tecvayli has been given conditional authorisation, the company that markets this medicine is required to submit the final results of the ongoing study in patients with multiple myeloma who were treated with Tecvayli. In addition, they will have to provide data from a study that compares the effectiveness of Tecvayli in combination with daratumumab (another cancer medicine) with that of other treatments currently authorised for use in adults with relapsed or refractory multiple myeloma.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tecvayli have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Tecvayli are continuously monitored. Suspected side effects reported with Tecvayli are carefully evaluated and any necessary action taken to protect patients.
Tecvayli received a conditional marketing authorisation valid throughout the EU on 23 August 2022. The conditional marketing authorisation was switched to a standard marketing authorisation on 20 August 2026.
Product information
Latest procedure affecting product information:VR/0000322279
20/08/2026
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
- Tecvayli
- International non-proprietary name (INN) or common name
- teclistamab
- Therapeutic area (MeSH)
- Multiple Myeloma
- Anatomical therapeutic chemical (ATC) code
- L01FX24
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Tecvayli is indicated
- in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
- as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
News on Tecvayli
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