Abecma
idecabtagene vicleucel
Table of contents
Overview
Abecma is a medicine used to treat adults with multiple myeloma (a cancer of the bone marrow) when the cancer has come back (relapsed) and has not responded to treatment (refractory). It is used in adults who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti‑CD38 antibody and whose disease has worsened since the last treatment.
Abecma is a type of advanced therapy medicine called ‘gene therapy’. This type of medicine works by delivering genes into the body.
Multiple myeloma is rare, and Abecma was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 April 2017. Further information on the orphan designation can be found here: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3171863
Abecma contains the active substance idecabtagene vicleucel.
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Abecma : EPAR - Medicine overview (PDF/137.93 KB)
First published: 25/08/2021
Last updated: 28/10/2021
EMA/370162/2021 -
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Abecma : EPAR - Risk-management-plan summary (PDF/390.17 KB)
First published: 25/08/2021
Authorisation details
Product details | |
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Name |
Abecma
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Agency product number |
EMEA/H/C/004662
|
Active substance |
idecabtagene vicleucel
|
International non-proprietary name (INN) or common name |
idecabtagene vicleucel
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01
|
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. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
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Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
18/08/2021
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Contact address |
Plaza 254 |
Product information
23/06/2023 Abecma - EMEA/H/C/004662 - PSUSA/00010954/202209
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
Abecma is indicated 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.