FDA gives its okay to a second gene therapy that can send blood cancer into remission
The FDA has approved a new gene therapy for adults with aggressive non-Hodgkin's lymphoma.
According to a recent story by Denise Grady in The New York Times, Yescarta was okayed for patients who've undergone two regimens of chemotherapy that failed.
The Times article notes that the therapy "is part of the rapidly growing field of immunotherapy, which uses drugs or genetic tinkering to turbocharge the immune system to fight disease. In some cases the treatments have led to long remissions."
The therapy, which turns cells into "living drugs," is made by Kite Pharma.
Approval by the Federal Drug Administration was its "second in a radically new class of treatments that genetically reboot a patient's own immune cells to kill cancer."
The first was Kymriah, made by Novartis. It was okayed in August "for children and young adults with an aggressive type of acute leukemia."
That one costs $475,000 per dose, although the company has said "it will not charge patients who do not respond within the first month after treatment."
Yescarta isn't quite as expensive — $373,000 per treatment.
|Dr. Frederick L. Locke|
Grady's story says "about 3,500 people a year in the United States may be candidates for Yescarta," which is intended "to be given once, infused into a vein, and must be manufactured individually for each patient."
Side effects, as with many therapies, can be daunting.
Life-threatening issues that stem from the Yescarta treatment can include "high fevers, crashing blood pressure, lung congestion and neurological problems," the story indicates.
According to Grady, two patients in the study that led to the drug's approval, "died from side effects," although doctors — through training and experience — apparently "have learned to manage them better."
The study, which was conducted at the Dana-Farber Cancer institute and Brigham and Women's Cancer Center in Boston, involved 111 patients at 22 hospitals.
"Initially," Grady's piece delineates, "54 percent [of the 101 who received Yescarta] had complete remissions…Another 28 percent had partial remissions [and] after six months, 80 percent…were still alive. With a median follow-up of 8.7 months, 39 percent of the 101 were still in complete remission — a much higher rate that achieved with earlier treatments — and 5 percent still had partial remissions."
|Dr. Caron A. Jacobson|
Says Dr. Caron A. Jacobson, who helped do the study: "You're really seeing people get their life back. After a couple weeks in the hospital and a couple weeks at home, they go back to work. On its face, it's quite remarkable and revolutionary."
The treatment, the Times explains, "was originally developed at the National Cancer Institute, by a team Dr. Steven Rosenberg led. The institute entered an agreement with Kite in 2012, in which the company helped pay for research and received rights to commercialize the results."
The drug giant Gilead reportedly bought Kite two months ago for $11.9 billion.
"In just several decades, said Dr. Scott Gottlieb, the FDA commissioner, "gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer."
A look at many treatments and clinical trials can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at caregivers.