Carvykti

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ciltacabtagene autoleucel

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

Overview

Carvykti 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.

Multiple myeloma is rare, and Carvykti was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 28 February 2020. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3202252

Carvykti contains the active substance ciltacabtagene autoleucel, consisting of genetically modified white blood cells.

This EPAR was last updated on 17/06/2022

Authorisation details

Product details
Name
Carvykti
Agency product number
EMEA/H/C/005095
Active substance
ciltacabtagene autoleucel
International non-proprietary name (INN) or common name
ciltacabtagene autoleucel
Therapeutic area (MeSH)
Multiple Myeloma
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
Janssen-Cilag International NV
Date of issue of marketing authorisation valid throughout the European Union
25/05/2022
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

Carvykti - EMEA/H/C/005095 -

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:

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

Not yet assigned

Therapeutic indication

Carvykti 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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