FDA approves cancer breakthrough that costs $375000 per treatment

Posted October 21, 2017

Each dose of the therapy is created using a patient's own T-cells, which are collected and genetically modified to incorporate a gene that targets and eradicates lymphoma cells. There are approximately 72,000 new cases of National Hockey League diagnosed in the United States annually. Dr. Locke helped run patient tests of Yescarta. The cells are extracted, then reprogrammed to fight cancer before they are reintroduced to the patient's body.

The FDA said diffuse large B-cell lymphoma is the most common type of non-Hodgkin's Lymphona in adults and there are approximately 72,000 new cases of National Hockey League diagnosed in the United States each year. "The approval of Yescarta brings this innovative class of CAR-T cell therapies to an additional group of cancer patients with few other options - those adults with certain types of lymphoma that have not responded to previous treatments", said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research. 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.

Kite's therapy is for patients with three types of aggressive, or fast-growing, large B-cell lymphoma. This was Kite's flagship cell-therapy treatment and will come with a more rapid payoff for Gilead's first large acquisition. "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", Scott Gottlieb, MD, FDA Commissioner, said in a statement. The FDA has approved the CD19-directed vehicle T-cell therapy axicabtagene ciloleucel (axi-cel; Yescarta) for people with large B-cell lymphoma following 2 prior therapies, including for those with diffuse large B-cell lymphoma (DLBCL).

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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. The FDA is also requiring hospitals to receive certification and staff to be trained how to administer the therapy and manage side effects, according to the release. Other side effects include infections, low blood cell counts, and dampened immune system.

The CAR T-cell therapy was approved with a boxed warning regarding CRS.

The American Cancer Society estimates that 72,240 people will be diagnosed with non-Hodgkins lymphoma this year and 20,140 people will die from it.

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The treatment was first developed at the National Cancer Institute, led by Dr. Steven Rosenberg, who signed an agreement with Kite Pharma in 2012.

The drug, which is called Yescarta (axicabtagene ciloleucel), would be used to treat adult patients with certain types of large B-cell lymphoma, a type of non-Hodgkin lymphoma, who have not responded to or who have relapsed after at least two other kinds of cure.

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