Abecma

RSS

idecabtagene vicleucel

Authorised
This medicine is authorised for use in the European Union.

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) or 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.

This EPAR was last updated on 25/08/2021

Authorisation details

Product details
Name
Abecma
Agency product number
EMEA/H/C/004662
Active substance
idecabtagene vicleucel
International non-proprietary name (INN) or common name
idecabtagene vicleucel
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01
Additional monitoringAdditional 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 approvalConditional 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.

OrphanOrphan

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
Marketing-authorisation holder
Celgene Europe BV 
Date of issue of marketing authorisation valid throughout the European Union
18/08/2021
Contact address

Winthontlaan 6 N
3526 KV Utrecht
Netherlands

Product information

18/08/2021 Abecma - EMEA/H/C/004662 -

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

Related content

How useful was this page?

Add your rating
Average
1 rating