by Hezi Sternlicht and Israel Hayom Staff
Yescarta is based on innovative technology that recruits the immune system to identify and destroy cancer cells • Drug is based on CAR-T therapy, developed by researchers at Weizmann Institute and Sourasky Medical Center
|
Professor Arie
Belldegrun
Photo: Kite Pharma
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.
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.
Hezi Sternlicht and Israel Hayom Staff
Source: http://www.israelhayom.com/2017/10/20/israeli-developed-breakthrough-cancer-drug-receives-fda-approval/
Follow Middle East and Terrorism on Twitter
Copyright - Original materials copyright (c) by the authors.
No comments:
Post a Comment