publication date: Oct. 20, 2017

FDA approves Kite’s CAR-T cell therapy; another win for NCI’s intramural program

By Matthew Bin Han Ong

FDA has approved Yescarta (axicabtagene ciloleucel), a genetically modified cell therapy, to treat adult patients with certain types of large B cell lymphoma who have not responded to or have relapsed after at least two other kinds of treatment.

Yescarta, approved Oct. 18, is the second chimeric antigen receptor T cell, or CAR-T, therapy to enter the market. It is also the first gene therapy for certain types of non-Hodgkin lymphoma.

Yescarta is sponsored by Kite Pharma, which was acquired for $12 billion by Gilead Sciences earlier this year. The treatment is priced at $373,000 per infusion.

This is arguably one of the most significant interventions to come out of the NCI intramural research program. Another field-changing contribution is the HPV vaccine, which was developed by NCI Deputy Director Douglas Lowy and John Schiller, deputy chief of the Laboratory of Cellular Oncology and head of the Neoplastic Disease Section at the NCI Center for Cancer Research. Lowy and Schiller received the 2017 Lasker-DeBakey Clinical Medical Research Award (The Cancer Letter, Sept. 8, Sept. 29).

“I would think this is a tribute to the intramural program, because we took on this method of treatment using cells for therapy, which doesn’t fit into conventional pharmaceutical companies,” Steven Rosenberg, chief of the Surgery Branch, senior investigator, and head of the Tumor Immunology Section at NCI’s Center for Cancer Research, said to The Cancer Letter. “As you know, they want drugs that they can put in a vial that you can ship around the world. I guess they’ll spend half-a-billion dollars to … Continue reading FDA approves Kite’s CAR-T cell therapy; another win for NCI’s intramural program

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