Israeli-Developed Breakthrough Cancer Drug Receives FDA Approval

A family in Massachusetts was hospitalized with carbon monoxide poisoning after they turned the heat on for the first time this season

Each treatment of the T-cell therapy is customized using a patient's own immune cells, starting with T cells collection via apheresis, shipment to a manufacturing facility, and genetic modification of the cells to express a vehicle specific to CD19, which is commonly over-expressed in B cell malignancies allowing the modified immune cell to target and kill the lymphoma cell. The FDA has approved a risk evaluation and mitigation strategy (REMS) for Yescarta that will inform and educate health care professionals about its associated risks. "From the release of our pivotal data for axi-cel [Yescarta], to our potential approval by the FDA, this is a year of milestones", he said. It's the second time the FDA has approved a gene therapy for use in the United States following a procedure meant to treat leukemia earlier this year.

Diffuse large B-cell lymphoma is the most common aggressive non-Hodgkin lymphoma, roughly three out of every five cases. Yescarta is also said to have a boxed warning on its product label regarding the risks of cytokine release syndrome and neurologic toxicities.

The drug, named Yescarta, was developed by Israeli-founded Kite Pharma and it is expected to cost some $373,000, likely generating hundreds of millions of dollars in sales.

Dr. Scott Gottlieb, commissioner of the FDA, noted in a statement announcing the approval Wednesday, how gene therapy has "gone from being a promising concept to a practical solution" for treating deadly forms of cancer in just several decades.

"It is important to note that the toxicities that we saw-CRS and neurological events-are generally reversible", lead investigator Frederick L. Locke, MD, medical oncologist at Moffitt Cancer Center, told Oncology Nursing News at the 2017 AACR Annual Meeting.


Potentially curative CAR-T therapies are poised to revolutionize blood cancer treatment, offering therapies tailored to the individual patient.

Yescarta is only the second gene-altering treatment approved by the FDA and the first for treating types of non-Hodgkin lymphoma, or adults suffering from large B-cell lymphoma.

To start, a doctor removes some white blood cells, the part of our body's immune system responsible for combatting infections and foreign substances, from a patient. Axicabtagene ciloleucel is a CAR-T cell therapy and is the second gene therapy to be approved by the FDA. Hospitals that provide the therapy will have to be specially certified, the FDA said. Using the patient's immune system to attack cancer cells can be very effective for treating malignancies and keeping cancer in remission, she noted.

Dr. Arie Belldegrun, founder of Kite, recognized "the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses". In the United States each year, approximately 7,500 patients with refractory DLBCL are eligible for CAR-T therapy.

Yescarta was initially developed by researchers at the National Cancer Institute in Washington, DC.

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