Innovative personalised immunotherapy approved for multiple myeloma
Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
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Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
The March meeting saw the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommend five medications for approval including a multiple myeloma gene therapy.
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
In the Phase Ib/II trial, cilta-cel achieved minimal residual disease negativity in 92 percent of patients and improved survival.
New trial data shows 98 percent of heavily pre-treated relapsed/refractory multiple myeloma patients responded to Janssen’s ciltacabtagene autoleucel (cilta-cel).