FDA approves 2nd gene therapy targeting non-Hodgkin lymphomas

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"It takes our most powerful immune cells in the body known as T-cells and it reengineers them to fight the B-cells that are causing the cancer in the first place", he said, adding that the innovation also has implications for more cancers.

DLBCL is the most common aggressive non-Hodgkin's lymphoma, accounting for three out of every five cases.

If you were to assign an all-in acceptance for Yescarta with 100% of the patients, that would generate close to $2.8 billion at the listed price from the full 100% patients per year. The patient's T-cells, a type of white blood cell, are collected, genetically modified to include a new gene that targets and kills the lymphoma cells, and infused back into the patient. In the United States alone, there are approximately 7,500 patients each year with refractory diffuse large B-cell lymphoma who are said to be eligible for vehicle T therapy.

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

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Diffuse large B-cell lymphoma is the most common type of the disease in adults, with some 72,000 new patients diagnosed annually in the United States, according to the American Cancer Society, and some 20,000 will die from it this year.

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. Yescarta (axicabtagene ciloleucel) has been approved by the U.S. Food and Drug Administration for individuals with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment.

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.

Because of these risks, FDA is requiring hospitals and associated clinics that dispense the treatment to be specially certified, including training to recognize and manage CRS and nervous system toxicities. "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. "That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies".

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Arie Belldegrun, the Israeli-American founder of Kite Pharma, referred to the promising research when commenting on Gilead's purchase of Kite in August. In the United States each year, approximately 7,500 patients with refractory DLBCL are eligible for CAR-T therapy.

"I believe this treatment approach brings hope to many patients, but one thing to consider is cost", said Almgren. While this therapy may be groundbreaking, it comes with potentially lethal side effects.

The cell-based gene therapy, which was developed by Gilead Sciences (GILD) Kite Pharma, will be used to treat patients who have not responded to or have relapsed after other treatments, and has had a 50% success rate, according to Dr. Siegel.

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