FDA Approvals, News & UpdatesLymphoma

Yescarta First CAR T-Cell Therapy FDA Approved for Patients with Large B-Cell Lymphoma

June 2022 Vol 8 No 3

In April 2022, the FDA approved Yescarta (axicabtagene ciloleucel; from Kite Pharma) for adults with large B-cell lymphoma that is refractory (not responding) to first-line chemoimmunotherapy or that has relapsed (returned) within 12 months of receiving first-line chemoimmunotherapy. Yescarta is the first CAR T-cell therapy to be approved for patients with this type of lymphoma.

“Definitive clinical trial results such as these do not come along often and should drive a paradigm shift in how patients with relapsed or refractory [large B-cell lymphoma] are treated moving forward. Patients who do not respond to or relapse after initial treatment should quickly be referred to a CAR T-cell therapy authorized treatment center for evaluation,” said Jason Westin, MD, Associate Professor, Department of Lymphoma/Myeloma, MD Anderson Cancer Center.

This approval was based on results of a clinical trial of 359 patients with relapsed or refractory large B-cell lymphoma. All the patients were candidates for stem-cell transplant.

The study included 359 patients who received either a single infusion of Yescarta after receiving lymphodepleting chemotherapy or a second-line standard chemoimmunotherapy, followed by a transplant in patients who had complete or partial remission.

The results showed that patients who received Yescarta had a significantly longer time without any adverse event. The response rate was 83% with Yescarta compared with 50% with standard therapy, a significant difference.

The most common nonlaboratory side effects reported with Yescarta are cytokine-release syndrome, fever, hypotension, encephalopathy, fatigue, tachycardia, headache, nausea, febrile neutropenia, diarrhea, musculoskeletal pain, infections, chills, and decreased appetite.

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Last modified: June 20, 2022

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