Tecvayli
teclistamab
Table of contents
Overview
Tecvayli is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow). It can be used in patients 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.
Tecvayli contains the active substance teclistamab.
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Tecvayli : EPAR - Medicine Overview (PDF/115.49 KB)
First published: 13/10/2022
EMA/788391/2022 -
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Tecvayli : EPAR - Risk management plan summary (PDF/366.79 KB)
First published: 13/10/2022
Authorisation details
Product details | |
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Name |
Tecvayli
|
Agency product number |
EMEA/H/C/005865
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Active substance |
Teclistamab
|
International non-proprietary name (INN) or common name |
teclistamab
|
Therapeutic area (MeSH) |
Multiple Myeloma
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Anatomical therapeutic chemical (ATC) code |
L01F
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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. |
Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International N.V.
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
23/08/2022
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Contact address |
Turnhoutseweg 30 |
Product information
22/06/2023 Tecvayli - EMEA/H/C/005865 - II/0003
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
TECVAYLI is indicated 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.