Stephenson gets initial clearance for new leukemia treatmentPublished: Thursday, November 30, 2017 By: Brian Brus Source: The Journal Record
The Stephenson Cancer Center has received clearance to prepare to offer a promising new cell therapy treatment for leukemia.
The center, part of the University of Oklahoma Health Sciences Center campus in Oklahoma City, must first be certified by the Food and Drug Administration, which officials expect to occur in early 2018. However, the Stephenson center had to be approved to even pursue that path, said Adam Asch, hematology/oncology section chief and professor.
Assuming everything goes as planned, the center will begin accepting patients for the radical new combination of gene and cell therapies shortly thereafter.
At the end of August, the FDA announced its approval for the first-ever gene therapy for the market, a therapy developed by pharmaceuticals giant Novartis Pharmaceuticals Corp. primarily for children with leukemia. A month later, the FDA approved Kite Pharma Inc.’s related cell treatment for adult lymphoma.
Acute lymphoblastic leukemia is the most common cancer among children in the United States, and it can be cured in a high percentage of patients with aggressive chemotherapy, according to the National Cancer Institute. However, patients who don’t respond to that approach haven’t had viable alternatives.
The new approach is more successful because it uses each patient’s own T cells, a subtype of white blood cells. The T cells are modified to enhance their ability to recognize and attack certain immune responder B cells that have gone bad. The modified T’s produce special surface connections called chimeric antigen receptors, or CARs.
The genetic engineering process to produce CAR T’s takes about three weeks, after which the cancer combat-ready cells are returned to the treatment center and reintroduced to the patient.
“It’s a complex process for the institution that offers it, as well as for the companies that are currently approved to participate,” Asch said. “Certification is really marrying the operating procedures of our institution with those companies.”
In addition to meeting strict CAR T standards for certification, the Stephenson center has also applied for NCI certification under the Cancer Centers Program of the National Cancer Institute. There are only 69 NCI-designated centers in 35 states so far. Asch said that clearance is also expected in the spring.
“What that means to OU and this cancer center is greater visibility throughout the nation, which can only be good for the citizens of Oklahoma,” he said. “We’ll be seen more and more as a destination for medical care.”
Stephenson center representatives said Thursday they were not allowed yet to confirm which pharmaceuticals party the center was partnering with. A formal public announcement is expected soon, they said.
The potential of CAR T therapy attracted a lot of attention from educated