FDA approves CAR T therapy for large B-cell lymphoma developed at Penn

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Credit: Penn Medicine

PHILADELPHIA – The U.S. Food and Drug Administration (FDA) has expanded approval for a personalized cellular therapy developed at the University of Pennsylvania’s Abramson Cancer Center, this time for the treatment of adult patients with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy. Today’s approval includes treatment of diffuse large B-cell lymphoma (DLBCL) – the most common form of non-Hodgkin’s lymphoma – as well as high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. The approval was granted today to Novartis for the chimeric antigen receptor (CAR) T-cell therapy Kymriah® (tisagenlecleucel, formerly CTL019), making it the second indication for the nation’s first personalized cellular therapy for cancer.

DLBCL affects approximately 30 percent of patients with NHL, and there are an estimated 27,000 newly diagnosed cases of DLBCL in the U.S. each year. About 6,500 of those patients have relapsed or refractory disease after two or more therapies and may now be eligible for Kymriah.

“This is an exciting event – seeing this lifesaving therapy become available widely to a large patient population with an unmet medical need,” said Stephen J. Schuster, MD, the Robert and


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