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On April 22, 2024, the European Commission granted approval to ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed/refractory multiple myeloma (RRMM) after one or more prior therapies, including an immunomodulatory agent (IMiD) or proteasome inhibitor (PI), who are lenalidomide-refractory with disease progression on the last therapy.1
The approval of this new indication for cilta-cel is based on data from the phase III CARTITUDE-4 trial (NCT04181827) in which patients with RRMM and 1–3 prior lines of therapy were randomized to receive either cilta-cel or a standard of care (SOC) regimen, consisting of daratumumab, pomalidomide, and dexamethasone (DPd) or pomalidomide, bortezomib and dexamethasone (PVd).1
Figure 1. Response data from CARTITUDE-4*
Cilta-cel, ciltacabtagene autoleucel; CR, complete response; ORR, overall response rate; PR, partial response; sCR, stringent complete response; SoC, standard of care; VGPR, very good partial response.
*Data from European Medicines Agency.2
Table 1. Adverse events of interest*
Adverse events, % |
Cilta-cel |
SoC |
---|---|---|
Grade 3/4 neutropenia |
90 |
82 |
Grade 3/4 thrombocytopenia |
41 |
19 |
Grade 3/4 anemia |
36 |
14 |
Serious AEs |
44 |
39 |
Infection |
62 |
71 |
CRS |
76 |
- |
AE, adverse event; cilta-cel, ciltacabtagene autoleucel; CRS, cytokine release syndrome; SoC, standard of care. |
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