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CAR-T Cell Therapy for Certain Lymphomas Approved

FDA news release; 2017 Oct 18

Publish date:: October 25, 2017

The FDA has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T cell therapy, to treat adult patients with certain types of large B-cell lymphoma.

Indications: Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Dosage and administration: Target dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells.

Efficacy and safety: Approval is based on results from a multicenter trial that resulted in a complete remission rate of 51% after treatment.

Side effects/risks: The most common adverse reactions are cytokine release syndrome, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

Citation:

FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma. [news release]. Silver Spring, MD: FDA. October 18, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm581216.htm. Accessed October 19, 2017.

Yescarta [package insert]. Santa Monica, CA: Kite Pharma, Inc. 2017. https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM581226.pdf. Accessed October 19, 2017.

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