The US Food and Drug Administration on Wednesday approved the second in a radically new class of treatments that genetically reboot a patient’s own immune cells to kill cancer.
Yescarta, made by biopharmaceutical company Kite, is a kind of gene therapy that combine medical and genetic techniques to equip the immune systems of patients to fight off diseases. It works by re-engineering a patient’s own immune system and transforming their own cells into a “living drug” that can identify and kill cancer cells.
The Yescarta gene-altering cancer treatment is made from re-engineered T cells which then encourage the body to fight off its cancer.
“Today is an important day for patients with relapsed or refractory large B-cell lymphoma who have run out of options and have been waiting for new treatments that may help them in their fight against cancer,” Gilead Sciences President and CEO John Milligan said in a press release (Gilead owns Kite as of 2016).
The treatment was approved for adults with aggressive forms of a blood cancer, non-Hodgkin’s lymphoma, who have undergone two regimens of chemotherapy that failed.
No Other Option
The new therapy, Yescarta, is approved only for adults who have had two or more failed chemotherapy regimens. In the US alone, about 3,500 people a year may be candidates for Yescarta. It is meant to be given once, infused into a vein, and must be manufactured individually for each patient. The cost will be US $373,000.
The treatment is risky, and can come with life-threatening side-effects, such as neurological problems, serious infections, and even death. However, since the eligible patients are facing such a high risk of death, most seem to think it’s worth the risk.
Tina Bureau, a lymphoma patient who participated in the drug’s study and is now in remission, told the New York Times no other treatment until Yescarta worked for her. “Yes, it can pose life threatening problems,” Bureau said. “But when you’re in a situation where your life’s threatened anyway, I don’t feel you have anything to lose.”
The New York Times reports that companies have been racing to develop new forms of immunotherapy. The first cell-based cancer treatment — Kymriah, made by Novartis — was approved in August for children and young adults with an aggressive type of acute leukemia. It will cost $475,000, but the company has said it will not charge patients who do not respond within the first month after treatment.