Kite's CAR-T therapy approved by FDA for second-line treatment of lymphoma

▎WuXi AppTec Content Team Editor Today, the U.
S.
Food and Drug Administration announced that it has approved the expanded scope of the CD19-targeted CAR-T therapy Yescarta (axicabtagene ciloleucel) developed by Kite Pharma, a subsidiary of Gilead Sciences, for the second-line treatment of large B-cell lymphoma (LBCL).
adult patients
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They developed resistance after first-line chemoimmunotherapy, or relapsed within 12 months of first-line therapy
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This therapy is not indicated for the treatment of patients with primary central nervous system lymphoma
.

According to a press release from Kite Pharma, this is "the first approved therapy to improve patient outcomes compared to standard therapy in nearly 30 years
.
"
Yescarta is the second FDA-approved CAR-T cell therapy, which guides and activates T cells to kill cancerous B cells by targeting the CD19 antigen on the surface of B cells
.

This approval is based on positive results from the randomized, open-label clinical trial ZUMA-7
.

A total of 359 patients were randomized to receive a single dose of Yescarta or standard second-line therapy
.

The primary efficacy endpoint was event-free survival (EFS)
.

The trial results showed that patients in the Yescarta group had significantly prolonged EFS (HR=0.
40, 95% CI: 0.
31, 0.
51; p<0.
0001)
.

The estimated EFS was 8.
3 months in the Yescarta group and 2.
0 months in the standard-care group
.

The independent review committee-assessed objective response rate in the Yescarta arm was 83%, significantly better than the 50% in the control arm
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In terms of safety, 90% of treated non-Hodgkin lymphoma patients developed cytokine release syndrome (CRS), and the proportion of grade 3 or higher CRS was 9%
.

The incidence of neurotoxicity was 78% (grade 3 or higher, 25%)
.

Christi Shaw, Chief Executive Officer of Kite, said: "Kite started with a very bold goal: to create hope for survival through cell therapy
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Today's FDA approval enables the power of CAR-T cell therapy to be harnessed earlier in the therapeutic journey, providing the More patients bring hope!" Reference: [1] FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma.
Retrieved April 1, 2022, from https:// /resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-second-line-treatment-large-b-cell-lymphoma[2] Yescarta® Receives US FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL).
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.

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