FDA approves Israeli-developed, personally tailored cancer-killer drug

Developed by researchers at Israel’s Weizmann Institute and Sourasky Medical Center, the U.S. Food and Drug Administration fast-tracked the approval for their cancer treatment Yescarta, based on technology that uses the patient’s immune system to destroy cancer cells.
• List price in U.S. for the personally tailored drug is $373,000.

By Hezi Sternlicht & Israel Hayom Staff


Kite Pharma, founded by Israeli-American Professor Arie Belldegrun in 2009, has announced that the U.S. Food and Drug Administration has granted regular approval for its cancer treatment Yescarta.

California-based Gilead Sciences bought Kite Pharma for $12 billion in August this year.

Professor Arie Belldegrun – Photo: Kite Pharma

The product, which was approved on a fast-track process, is based on innovative technology that recruits the body’s immune system to identify and destroy cancer cells.

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.

Thus far, according to reports, 100 patients have been treated with Yescarta.

There were concerns that the FDA would not approve the treatment, but it was ultimately approved due to the convincing clinical information and the lack of an alternative for the kind of cancer the product treats.

Yescarta is based on CAR-T therapy, which was developed by Israeli researchers at the Weizmann Institute of Science and Tel Aviv Sourasky Medical Center. It represents 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.

According to Gilead, the T cells can be produced within 17 days with 99% success. The product will carry a warning about cytokine release syndrome, a side effect that can cause lethal brain damage.

The product is, however, limited for the time being in the indication for which it can be prescribed, until further information is obtained.

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

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

“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,” Belldegrun said. “We believe this is only the beginning for CAR-T therapies.”

As a result of the FDA approval, Gilead Science shares saw a 0.7% rise on Wall Street on Thursday, while the company’s worth is now estimated at $105.2 billion.


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