FDA approves new cancer treatment with Israeli pedigree

Arie Belldegrun Photo: PR
Arie Belldegrun Photo: PR

Gilead Sciences unit Kite Pharma's Yescarta is engineered from the patient's own T cells.

Kite Pharma, bought by Gilead Sciences (GILD) for $12 billion in August this year, has announced that the US Food and Drug Administration (FDA) has granted regular approval to its cancer treatment Yescarta (axicabtagene ciloleucel).

The product was approve on a fast-track process. Because of the combination of this process and the innovativeness of the product there were fears until the last minute that the FDA would get cold feet and not approve it, but in the end, thanks to convincing clinical information and the because of the lack of an alternative for the kind of cancer that the product treats, it was approved. The product is, however, limited for the time being in the indication for which it can be prescribed, until further information is obtained.

Yescarta is approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of conventional therapy.

Yescarta is based on CAR T therapy, a breakthrough in hematologic cancer treatment in which a patient’s own T cells are engineered to seek and destroy cancer cells. CAR T therapy is manufactured specifically for each individual patient. Gilead states that the T cells can be produced within 17 days with 99% success. Speedy production is important, as the patient's condition continues to deteriorate during the preparation period. The product will carry a warning about CRS (cytokine release syndrome), a side-effect that can cause lethal brain damage.

"The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B-cell lymphoma. This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite’s employees," said Kite Pharma founder Arie Belldegrun. "We believe this is only the beginning for CAR T therapies."

Kite Pharma was founded in the US by the Israeli-born and educated Belldegrun partly on the basis of inventions by Prof. Zelig Eshhar of the Weizmann Institute of Science and Ichilov Hospital.

Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive non-Hodgkin lymphoma (NHL), accounting for three out of every five cases. According to Gilead Sciences, in the US each year, there are approximately 7,500 patients with refractory DLBCL who are eligible for CAR T therapy.

The treatment is extremely expensive. The list price of Yescarta in the US is $373,000.

Yescarta has been granted Priority Medicines (PRIME) regulatory support for DLBCL in the European Union. A Marketing Authorization Application (MAA) for axicabtagene ciloleucel is currently under review with the European Medicines Agency (EMA) and potential approval is expected in the first half of 2018.

Published by Globes [online], Israel business news - www.globes-online.com - on October 19, 2017

© Copyright of Globes Publisher Itonut (1983) Ltd. 2017

Arie Belldegrun Photo: PR
Arie Belldegrun Photo: PR
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