DLBCL is the most common aggressive non-Hodgkin's lymphoma, accounting for three out of every five cases. To date, 100 patients have reportedly been treated with Yescarta.
To make each dose of Yescarta, the patient's T-cells - a type of white blood cell - are collected and then genetically modified to include a new gene that targets and kills the cancer cells.
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 treatment will cost almost $375,000, which is $100,000 less than the first FDA-approved CAR-T treatment.
"Both CRS and neurologic toxicities can be fatal or life-threatening", the FDA warned.
Kite Pharma, which was recently acquired by Gilead, plans to market axi-cel at a list price of $373,000.
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"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 Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies", Scott Gottlieb, MD, FDA Commissioner, said in a statement. The therapy was approved for treating certain types of large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma). Other potential 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.
The novel T-cell therapy was approved after showing high levels of complete remission (CR) in a phase 2 study known as ZUMA-1. "This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite's employees", Kite founder Dr. Arie Belldegrun said.
The CAR T-cell therapy was approved with a boxed warning regarding CRS. Because not everybody with these advanced forms of cancer respond to the treatment, if patients don't respond to Kymriah within a month, the patient doesn't have to pay for it. Yescarta did not make the same arrangement.
Yescarta was initially developed by researchers at the National Cancer Institute in Washington, DC. While this therapy may be groundbreaking, it comes with potentially lethal side effects.