idecabtagene vicleucel

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 27/07/2023

Authorisation details

Product details
Agency product number
Active substance
idecabtagene vicleucel
International non-proprietary name (INN) or common name
idecabtagene vicleucel
Therapeutic area (MeSH)
  • Multiple Myeloma
  • Neoplasms
  • Cancer
  • Neoplasms, Plasma Cell
  • Hemostatic Disorders
  • Vascular Diseases
  • Cardiovascular Diseases
  • Paraproteinemias
  • Blood Protein Disorders
  • Hematologic Diseases
  • Hemic and Lymphatic Diseases
  • Hemorrhagic Disorders
  • Infectious Mononucleosis
  • Lymphoproliferative Disorders
  • Immunoproliferative Disorders
  • Immune System Diseases
Anatomical therapeutic chemical (ATC) code
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.


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
Bristol-Myers Squibb Pharma EEIG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867

Product information

23/06/2023 Abecma - EMEA/H/C/004662 - PSUSA/00010954/202209

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Product information documents contain:

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.

Assessment history

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