Gilead Sciences shares bolstered after FDA approval validates Kite Pharma merger

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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. There are approximately 72,000 new cases of National Hockey League diagnosed in the United States annually. The FDA cautions that the drug is not indicated to treat patients with primary central nervous system lymphoma. "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".

The FDA has approved a second cancer treatment using gene therapy, and the first to target non-Hodgkins lymphomas.

In a pivotal clinical trial of more than 100 adults, 51 percent of patients treated with Yescarta achieved complete remission, far higher than what is typical with current standard-of-care treatments.

The adverse effect profile remains the same for this treatment as for tisagenlecleucel-the drug has a boxed warning for cytokine release syndrome and for neurologic toxicities, which can both be fatal or life-threatening.

The drug will be marketed as Yescarta and sell at a price of US$373,000.

Gilead's new approval is also for a broader patient population than the Novartis drug Kymriah. Commissioner Scott Gottlieb announced alongside the approval that FDA will soon issue a comprehensive agency policy clarifying how FDA's expedited programs apply to gene therapy products. Patients must be informed of these risks before receiving the therapy.

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The FDA has given the go-ahead for a second chimeric antigen receptor (CAR) T cell therapy: axicabtagene ciloleucel (Yescarta), developed by Kite Pharma, which was recently acquired by Gilead Sciences, has been approved to treat adult patients with diffuse large B-cell lymphoma (DLBCL) who have not responded to or who have relapsed after at least 2 other kinds of treatment.

The highly personalized cancer treatment is a type of vehicle T-cell therapy (CAR is short for chimeric antigen receptor).

"The acquisition of Kite establishes Gilead as a leader in cellular therapy and provides a foundation from which to drive continued innovation for people with advanced cancers", GILD CEO, John F. Milligan, Ph.D., said in a statement.

Put simply, this is a type of product, which aims to help the immune system identify and target cancer cells.

"We believe this is only the beginning for CAR-T therapies", said Belldegrun in a statement.

Yescarta was initially developed by researchers at the National Cancer Institute in Washington, DC. The therapy is still working in most study participants, so the average duration of its effects isn't known yet.

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