EU CHMP gives green light to two CAR-T therapies, Carvykti and Kymriah

Multiple myeloma patients treated with immunomodulatory drugs, proteasome inhibitors, and anti-CD38 antibodies eventually relapse or are refractory to these treatments, resulting in a poor prognosis
.

Among refractory patients with tertiary exposures, 31% had a median overall survival of 9.

Multiple myeloma patients treated with immunomodulatory drugs, proteasome inhibitors, and anti-CD38 antibodies eventually relapse or are refractory to these treatments, resulting in a poor prognosis

CAR-T lymphoma

Specifically, the CHMP recommends Carvykti for the treatment of adults with relapsed/refractory (r/r) multiple myeloma who have received at least three prior therapies, including immunomodulators, proteasome inhibitors, and anti-CD38 antibodies
.

The CHMP support is supported by the results of the phase Ib/II CARTITUDE-1 study, which showed that patients in the Carvykti arm produced an overall response rate of 97% and a strict response rate of 67% after approximately one year of follow-up

The CHMP support is supported by the results of the phase Ib/II CARTITUDE-1 study, which showed that patients in the Carvykti arm produced an overall response rate of 97% and a strict response rate of 67% after approximately one year of follow-up

Figure 1.
Patient PFS

Figure 1.
Patient's PFSFigure 1.
Patient's PFSFigure 1.
Patient's PFS

This single-arm, open-label, Phase Ib/II study (CARTITUDE-1) at 16 U.
S.
centers enrolled patients 18 years of age or older with a diagnosis of multiple myeloma and an ECOG PS of 0-1 , they received 3 or more prior lines of therapy
.

A single infusion of Carvykti (target dose of 0.

Diagnosis ⁶

 

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