Published: Sat, October 21, 2017
Markets | By Lucia Cruz

Gilead Jumps After FDA Approves Its Kite-Acquired CAR-T Drug

Gilead Jumps After FDA Approves Its Kite-Acquired CAR-T Drug

It is a development that moves cancer treatment in general another step forward into the future.

"Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer", said FDA Commissioner Scott Gottlieb, MD, in a statement announcing the approval.

The approval was based on complete remission (CR) rates in the phase II ZUMA-1 trial.

Gilead has listed axicabtagene ciloleucel at $373,000 in the United States, much cheaper than the launch price of tisagenlecleucel at $475,000.

The therapy will be manufactured in Kite's commercial manufacturing facility in El Segundo, CA, which the company opened in June 2016. Prior to infusion of axi-cel, a conditioning regimen of fludarabine and cyclophosphamide was administered. The modified T-cells are infused back into the patient for treatment.

USA regulators have approved a second form of gene therapy to fight cancer. About half of all patients with large B-cell lymphoma relapse or become resistant to current treatments, which may include chemotherapy, stem cell transplants, and immunotherapy, the broadcaster noted. After 8.7 months of follow-up, the ORR in the DLBCL group was 36%, which included a CR rate of 31%.

In the key test, Yescarta was given to 101 patients. The median overall survival (OS) was not yet reached at the time of the analysis. The process takes an average of 17 days from receipt of the patient's white blood cells. Many experience cytokine-release syndrome, a response to the reprogrammed cells running loose in the body.

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The FDA is also requiring that Kite continue to conduct observational studies of patients treated with Yescarta. The first 2 reported were from hemophagocytic lymphohistiocytosis and cardiac arrest in the setting of CRS.

Significantly, it is the first CAR-T drug approved for those patients. The required training will focus on identifying and managing CRS and neurologic toxicity.

The market capitalization of Gilead is now reeling at 104.65B based on its aggregate value over its current share price and the total amount of outstanding stocks.

He said the advancement of cell therapy research, which produced Yescarta, will help bring more options to patients with other forms of cancer.

Yescarta uses gene therapy techniques called CAR-T to boost the capacity of T cells, the immune-system cells that cancer can evade.

The approval comes as the FDA is set to offer more guidance to manufacturers on the development of gene therapies similar to Yescarta.

A different type of gene therapy is waiting in the wings at the FDA. We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine. 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 auto specific to CD19, which is commonly over-expressed in B cell malignancies allowing the modified immune cell to target and kill the lymphoma cell.

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