CAR-T drugs are made using a patient's own immune cells.
Adults with relapsed or refractory non-Hodgkin lymphoma (NHL) now have new hope. A patient's T-cells are collected and genetically modified to include a new gene that targets and kill lymphoma cells. The therapy was evaluated in a multicenter clinical trial involving more than 100 adults, where the complete remission rate after treatment with Yescarta was 51 percent, the FDA said.
Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in a statement, "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".
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 U.S., according to the American Cancer Society, and some 20,000 will die from it this year.
Yescarta is administered once through the vein and will cost $373,000 for the shot.
All patients had chemorefractory disease and had received a median of 3 prior lines of therapy, with 54% refractory to 2 consecutive lines of therapy.
Kite Pharma's Yescarta (axicabtagene ciloleucel), marking the second gene therapy approved in the United States and the first for certain types of non-Hodgkin lymphoma. "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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Potentially curative CAR-T therapies are poised to revolutionize blood cancer treatment, offering therapies tailored to the individual patient.
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. Also, patients must be informed of the potential serious side effects and of the importance of promptly returning to the treatment site if side effects develop.
Yescarta is the second CAR-T treatment approved by the FDA. "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".
Put simply, this is a type of product, which aims to help the immune system identify and target cancer cells.
The CAR T-cell therapy was approved with a boxed warning regarding CRS.
"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 was first developed at the National Cancer Institute, led by Dr. Steven Rosenberg, who signed an agreement with Kite Pharma in 2012. The therapy is still working in most study participants, so the average duration of its effects isn't known yet.