FDA Approves CAR T-Cell Therapy for Large B-Cell Lymphoma

Officials with the FDA have expanded the approval for the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah, Novartis) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy, according to a press release.

The approval includes the treatment of diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

The FDA initially approved tisagenlecleucel in August 2017 for children and young adults with relapsed or refractory B-cell precursor acute lympoblastic leukemia (ALL), making it the first FDA-approved therapy based on gene transfer.

According to the press release, the therapy works by modifying patients’ own immune T cells, which are collected and reprogrammed at the Novartis manufacturing facility to potentially seek and destroy the patient’s lymphoma cells. Once infused back into the patients’ bodies, the newly built cells multiply and attack, targeting cells that express the CD19 protein.

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