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EMA Product

Carvykti

Product approved by European Medicines Agency (EU)

Basic Information

Carvykti

Regulatory Information

EMEA/H/C/005095

Authorised

May 25, 2022

March 24, 2022

10

September 25, 2024

Company Information

Belgium

Turnhoutseweg 30 B-2340 Beerse

Janssen-Cilag International NV

Drug Classification

Orphan MedicineConditional ApprovalAdditional MonitoringAdvanced Therapy

Active Ingredients

Active Substances Detail

Detailed Information

Overview Summary

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 one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, whose disease has worsened since the last treatment, and for whom treatment with lenalidomide did not work (refractory). 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 in the [orphan designation page](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2252). Carvykti contains the active substance ciltacabtagene autoleucel, consisting of genetically modified T cells (a type of white blood cells).

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