Ciltacabtagene autoleucel

Ciltacabtagene autoleucel (Carvykti, Janssen-Cilag International NV) has 1 EU-approved indication in 1 tumour type.
Approved indications of Ciltacabtagene autoleucel
Biomarker requirementRegimenSettingConditions
Multiple myeloma1
None
Monotherapy
2L
After at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor; disease progression on the last therapy; refractory to lenalidomide
Full text of section 4.1 (therapeutic indications)

CARVYKTI is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.

Label history

18 changes to the Carvykti label since 2023, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes