Tisagenlecleucel (Kymriah, Novartis) is now approved for the treatment of diffuse large B-cell (DLBCL) lymphoma, as well as high grade B-cell lymphoma and DLBCL arising from follicular 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.
“This is an exciting event—seeing this lifesaving therapy become available widely to a large patient population with an unment medical need,” Stephen J Schuster, MD, the Robert and Margarita Louis-Dreyfus Professor in chronic lymphocytic leukemia and lymphoma clinical care and research, and director of the lymphoma program at Penn’s Abramson Center of Medicine, said in the press release.
According to data from the Novartis-sponsored JULIET trial, patients treated with tisagenlecleucel showed an overall response of 53%, with 40% of patients achieving a complete response among the 81 infused patients with 3 or more months of follow-up or earlier discontinuation. At 6-month analysis, the median duration of response was not reached.
Fifty-eight percent of patients in the study experienced cytokine release syndrome (CRS), a toxicity associated with CAR T therapy. CRS includes varying degrees of flu-like symptoms, with fevers, nausea, and muscle pain, and can require ICU-level care.
According to the press release, tisagenlecleucel will be available through a network of certified treatment centers throughout the United States, including the Hospital of the University of Pennsylvania.
FDA Approves CAR T Therapy for Large B-Cell Lymphoma Developed at University of Pennsylvania [news release]. Penn Medicine’s website. Philadelphia. https://www.pennmedicine.org/news/news-releases/2018/may/fda-approves-car-t-therapy-for-large-b-cell-lymphoma-developed-at-university-of-pennsylvania. Accessed May 3, 2018.