FDA approves gene therapy to treat adult lymphoma
The Food and Drug Administration has approved a treatment that genetically alters patients’ cells to attack cancer in fighting non-Hodgkin lymphoma.
Dr. Mounzer Agha, director of the Lemieux Center for Blood Cancers at UPMC Hillman Cancer Center, Thursday called the treatment a “paradigm shift” in cancer therapy.
“In a short period of time this could completely change landscape of treating blood cancer,” Agha told the Tribune-Review.
The treatment, called Yescarta, will cost $373,000 per patient, according to drugmaker Gilead Sciences.
UPMC is offering the treatment to patients and has been involved in clinical trials with therapy.
Gilead, which recently acquired Kite Pharma, said Yescarta is to be administered only one time to each patient, barring relapse.
The price is below that of the first drug in this new class — Novartis AG’s $475,000 Kymriah. The Novartis gene therapy was approved in August for B-cell acute lymphoblastic leukemia, the most common form of childhood cancer in the United States, Reuters reported.
Both drugs reprogram the body’s immune cells to recognize and attack malignant cells.
“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,” FDA Commissioner Scott Gottlieb said in a statement. “This approval demonstrates the continued momentum of this promising new area of medicine and we’re committed to supporting and helping expedite the development of these products.”
The American Cancer Society estimates that 72,240 people will be diagnosed with non-Hodgkin lymphoma this year and 20,140 people will die from it. This type of lymphoma accounts for about 4 percent of all cancers in the United States.
Each dose of Yescarta is a customized treatment created using a patient’s own immune system to help fight the lymphoma, the FDA said in a statement. The patient’s T-cells, a type of white blood cell, are collected and genetically modified to include a new gene that targets and kills the lymphoma cells. Once the cells are modified, they are infused back into the patient.
Side effects include life-threatening fevers triggered by the immune response the therapy called cytokine release syndrome .
The safety and efficacy of Yescarta were tested clinical trial of more than 100 adults with refractory or relapsed large B-cell lymphoma, the FDA said. The complete remission rate after treatment with Yescarta was 51 percent.
Agha said the 51 percent figure is impressive.
“That is a very high response, almost unheard of,” he said.