The US Food and Drug Administration (FDA) has granted approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s first cell therapy Carvykti (ciltacabtagene autoleucel; cilta-cel) to treat relapsed or refractory multiple myeloma (RRMM) in adults.
Carvykti is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy.
According to the latest development, it is indicated for usage following four or more previous lines of therapy, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
The FDA approval is based on results from the open-label, multicentre ongoing Phase Ib/II CARTITUDE-1 clinical trial of ciltacabtagene autoleucel to treat 97 RRMM patients, who were earlier treated with PI, IMiD and an anti-CD38 monoclonal antibody.
The enrolled participants earlier received a median of six treatment regimens and progressed on or after the last treatment
Findings showed that a one-time treatment with ciltacabtagene autoleucel offered deep and long-lasting responses.
According to the two-year follow-up data, 98% of the subjects in the ciltacabtagene autoleucel arm responded to the treatment.
Furthermore, most of the participants attained a sustained depth of response with 83% of them having a stringent complete response (sCR) at the 22-month follow-up.
Currently, the trial is analysing the durable safety and efficacy profile of ciltacabtagene autoleucel.
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