The company claimed that its Yescarta is the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent follicular lymphoma
High magnification micrograph of a primary mediastinal large B-cell lymphoma. (Credit: Nephron/Wikipedia.)
Kite, a subsidiary of Gilead Sciences, has received the US Food and Drug Administration (FDA) accelerated approval for its Yescarta (axicabtagene ciloleucel) to treat a type of follicular lymphoma (FL).
The US regulatory agency indicated Yescarta for relapsed or refractory FL in adults, after two or more lines of systemic therapy.
Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy previously indicated for the treatment of large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL.
The drug is not indicated for patients with primary central nervous system lymphoma.
Kite said that the FDA approval, following FDA Breakthrough Therapy Designation and a priority review, marks the third approved indication for cell therapy.
Also, Yescarta is the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent follicular lymphoma.
The US FDA approved Yescarta based on results from ZUMA-5, a single-arm, open-label, ongoing clinical trial, evaluating 146 patients with relapsed or refractory iNHL, who received at least two prior lines of systemic therapy.
An independent review committee assessed the efficacy of the treatment, established on the basis of objective response rate (ORR) and duration of response (DoR).
The study showed that 91% of patients with relapsed or refractory FL responded to Yescarta, including an estimated 74% of patients in a continued remission at 18 months.
Kite is offering Kite Konnect, an integrated technology platform, for patients whose healthcare professionals prescribed Yescarta therapy.
The integrated platform is designed to offer information and assist the patients throughout the therapy process.
Kite CEO Christi Shaw said: “As we look to bring the hope of survival to more patients in need, today’s FDA decision represents a real step forward in our commitment in hematologic malignancies.
“Advancing CAR T therapies for patients across lymphomas remains a cornerstone of our cell therapy development program, and we are excited about the potential of Yescarta for patients with indolent follicular lymphoma.”