Israeli-Developed Breakthrough Cancer Drug Receives FDA Approval

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ISTOCK, 7ACTIVESTUDIOThe Food and Drug Administration yesterday (October 18, 2017) approved the chimeric antigen receptor (CAR) T-cell therapy Yescarta to treat patients with certain types of large B-cell lymphomas who have relapsed or not responded to two other types of cancer treatments.

Auto T-cell therapies work by engineering a patient's own immune cells to target cancer cells. Like Yescarta, Kymriah was also approved only for patients for whom other therapies have twice failed. "Together, Gilead and Kite will accelerate studies of CAR-T therapy in multiple blood cancers and advance other cell therapy approaches for solid tumors, with the goal of helping patients with diverse cancers benefit from this new era of personalized cancer therapy". These can include life-endangering neurologic toxicities - with symptoms of headache, limb numbness, loss of memory, vision, and/or intellect - and cytokine release syndrome, when a storm of immune proteins called cytokines are released into a patient's circulatory system. The need for new treatments is dire; only seven percent of patients with refractory large B-cell lymphoma who receive the current standard of care attain a complete response, and as a group the patients typically have a median overall survival of about six months. In the United States each year, there are approximately 7,500 patients with refractory DLBCL who are eligible for CAR-T therapy, Gilad said in a statement. Less than two months later on May 26, the FDA granted Yescarta Priority Review-under which the agency set a goal of taking action on Kite's vehicle T-cell candidate within 6 months.

Michaela Almgren, a clinical assistant professor at University of South Carolina College of Pharmacy, pointed out this will not be available in just any facility due to the many challenges surrounding extraction of a patient's T-cells, adjustment of genes, and reengineering the cells in sufficient quantity.

"It is not just something that the hospital or treatment center can order and then put on the shelf", said Almgren. Yescarta also received the FDA's Breakthrough Therapy and Orphan Drug designations. In addition, the packaging must include a warning to alert patients of the risks.

"We believe this is only the beginning for vehicle T therapies", Arie Belldegrun, MD, FACS, founder of Kite, said in a statement.

The FDA is now considering an unrelated gene therapy to treat an inherited form of blindness.




Arie Belldegrun, the Israeli-American founder of Kite Pharma, referred to the promising research when commenting on Gilead's purchase of Kite in August.

"We believe this is only the beginning for CAR-T therapies", said Belldegrun in a statement. The first one - Novartis Pharmaceuticals Corp.'s Kymriah, approved in August - was cleared only for leukemia patients up to 25 years old.

Almgren said the approval of Yescarta is "certainly very exciting".

"I really do think this is the future of oncology", Bishop said.

Development of the treatment began at the National Cancer Institute, then moved to Kite in 2012, The New York Times reports.

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