Gilead's Lymphoma Drug Gets Approved

Jon Howard
October 21, 2017

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. These are then sent to a facility in El Segunda, California - which Kite opened in June a year ago - where they are stimulated to proliferate and transduced with a retroviral vector to introduce the auto sequence into the patient's T cells before being propagated in cell culture bags. FDA made waves when it announced earlier this year.

The FDA approved a second gene therapy to treat cancer, called Yescarta.

"Both CRS and neurologic toxicities can be fatal or life-threatening", the FDA warned.

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 first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL). "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.

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Nearly all these deaths occurred in low and middle income countries, where pollution could account for up to a quarter of deaths. The Lancet medical journal study suggests at least nine million people died around the globe in 2015 because of pollution.

According to Gilead, about 7,500 lymphoma patients each year in the United States would be qualified for CAR-T treatment. Additionally, certification and training will be required before hospitals will be cleared to administer the T cell therapy.

"Other side effects include serious infections, low blood cell counts and a weakened immune system". In a healthy body, the immune system can recognize abnormal, cancerous cells, but for people with cancer, it doesn't recognize that the cells are spreading. Arie Belldegrun, MD, FACS, Founder of Kite, said in a statement.

"I believe this treatment approach brings hope to many patients, but one thing to consider is cost", said Almgren.

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.

Dr. David Maloney, medical director of cellular immunotherapy at Fred Hutchinson Cancer Research Center, helped develop the therapy and said the FDA's second approval of a CAR-T cell therapy "validates the revolution underway in the field of cellular immunotherapy". The therapy is still working in most study participants, so the average duration of its effects isn't known yet.

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