FDA Approves Radical New Gene-Altering Cancer Treatment
It transforms the patient's cells into "living drugs."
“Living Drug” for Cancer
On 18 October the Food and Drug Administration (FDA) approved the second gene-altering cancer treatment for patients with diffuse large B-cell lymphoma (DLBCL), the most common aggressive type of non-Hodgkin lymphoma (NHL), a blood cancer. The new therapy, Yescarta, is now approved only for adults who have had two or more failed chemotherapy regimens.
Yescarta, made by biopharmaceutical company Kite, is a kind of gene therapy. 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. This is a type of immunotherapy, treatments that combine medical and genetic techniques to equip the immune systems of patients to fight off diseases. In certain instances, these therapies have led to significant remissions, and even cures.
“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).
Nothing to Lose
Three of every five cases of aggressive NHL are the DLBCL variety. There are about 7,500 patients with refractory DLBCL in the US annually who are eligible for CAR T therapy. The need for new treatments is dire; only seven percent of patients with refractory large B-cell lymphoma who receive the current standard of care attain a complete response, and as a group the patients typically have a median overall survival of about six months. Right now, almost half of patients with large B-cell lymphoma who survive to undertake second or later lines of therapy do not respond to treatment, and relapse quickly.
About 3,500 Americans each year could be candidates for Yescarta, a one-time intravenous infusion that is individually manufactured for each patient at a cost of $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.”