This type of lymphoma accounts for about 4 percent of all cancers in the United States.
Gilead shares stand at US$80.01 in NY.
Diffuse large B-cell lymphoma, which is the most common form of non-Hodgkin lymphoma, represents about one in three newly diagnosed cases. 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. "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 Food and Drug Administration Commissioner Scott Gottlieb in a statement. He called the approval a "milestone".
A deal was struck with Kite Pharma to develop the drug. This newer drug class is not immune to problems, but it also brings great promise for those patients who struggle to beat cancer. 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.
Side effects can be severe, even fatal, particularly in the first couple of weeks after treatment. This syndrome causes symptoms such as fever, nausea, chills, tachycardia, and headache.
Michaela Almgren, a clinical assistant professor at University of South Carolina College of Pharmacy, pointed out this will not be available in just any facility due to the many challenges surrounding extraction of a patient's T-cells, adjustment of genes, and reengineering the cells in sufficient quantity. To further evaluate long-term safety, FDA is also requiring that the manufacturer conduct a post-marketing observational study on patients treated with the therapy.
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 highly personalized cancer treatment is a type of auto T-cell therapy (CAR is short for chimeric antigen receptor).
The FDA is now considering an unrelated gene therapy to treat an inherited form of blindness. "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".
The CAR T-cell therapy was approved with a boxed warning regarding CRS.
The approval of Yescarta is supported by data from the ZUMA-1 pivotal trial.
The product, which the FDA approved on a fast-track process, is based on innovative technology that recruits the body's immune system to identify and destroy cancer cells.
"Today's approval of Yescarta is a very significant advance for lymphoma patients and for the cancer community as a whole", Louis J. DeGennaro, president of the Leukemia & Lymphoma Society, said in a statement. The treatment is expensive - priced at $373,000 according to Gilead. The therapy is not indicated for treating primary central nervous system lymphoma.