US approves Gilead’s blood cancer cell therapy

Yescarta is considered the first choice after chemotherapy for adults with advanced blood cancers.

This one-time treatment was initially approved in 2017 for patients with Lymphoma large B cells unresponsive to at least two previous courses of treatment.

Yescarta is part of a treatment called CAR-T, which involves taking blood cells from a patient’s immune system, transporting them to a factory to be redesigned to fight certain diseases. better cancer and then returned to the patient.

According to Christi Shaw, Kite’s CEO, the FDA’s decision will increase to about 14,000 from 8,000 eligible lymphoma patients.

This treatment has a list price in the US of $ 399,000.

The treatment is a new therapy that aims to re-engineer a patient’s immune cells. (Photo: Alamy)

“The current standard of care is a difficult process. With the new FDA decision, patients will have earlier access to this potentially curative treatment,” said Lee Greenberg, chief scientific officer of the FDA. Leukemia & Lymphoma Association, said in a statement.

The results of the Kite trial showed that Yescarta improved patient survival by 60% without serious complications compared with chemotherapy and stem cell transplantation in secondary B-cell large lymphoma. two.

The National Comprehensive Cancer Network, the most influential source for cancer treatment guidelines in the United States, lists Yescarta as a first-line treatment for these patients.

The FDA says the drug’s label warns of a serious complication associated with CAR-T therapy called cytokine release syndrome, which can cause a dangerous array of symptoms including fever and neurological problems. .

According to Kite, there are about 100 authorized treatment centers in the US and 270 worldwide.

Kite is building a new CAR-T treatment facility in Maryland, expanding capacity from its current locations in Amsterdam and El Segundo, California.

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