FDA panel endorses cancer therapy performed in clinical trials at Nebraska Medicine – KETV Omaha

OMAHA, Neb.

A Food and Drug Administration panel this week endorsed what could be a groundbreaking cancer treatment. The panel of 10 voted unanimously to recommend CAR T-Cell therapy for children and young adults with acute lymphoblastic leukemia, or ALL.

In the next few months, the FDA could decide to approve the therapy, which would make it the first gene therapy available in the U.S. The therapy is already being used at Nebraska Medicine for clinical trials.

Doctors diagnosed Roger Belohlavy with ALL in August 2015. The cancer returned even after a bone marrow transplant.

"Disappointed that it came back, but I managed in spite of that disappointment (to) keep a pretty good attitude," said Belohlavy.

Belohlavy had few treatments options to consider, but his doctor at Nebraska Medicine proposed a CAR T-Cell clinical trial.

"He said the clinical trial is pretty promising because it could give you a more durable remission and possibly even lead to a cure," Belohlavy said.

Through CAR T-Cell therapy, doctors take T cells from the patient.

"I always describe it as, like, a cream separator, where the patient's blood comes out, we spin in through a cream separator, we open the door right where we want the T cells at," said Dr. Matthew Lunning, hematologist and oncologist at Nebraska Medicine.

The cells are then sent off to a processing center where they're "trained" to take out a person's cancer. The patient undergoes chemotherapy and then gets an infusion with the modified T cells.

"When you inject it back into the patient, it goes out there and is like a trained assassin," Lunning said.

The T cells kill the cancerous cells, but there are risks associated with the treatment.

"I went out with the neurotoxic reaction," said Belohlavy. "I was on life support for 7 1/2 days on a ventilator."

Days later, Belohlavy said, doctors told him he was in complete remission.

"It's given me a whole different outlook on what I want to do with my future," said Belohlavy.

CAR T-cell therapy could also help give others a brighter future. The FDA will soon decide whether to officially approve the treatment for young ALL patients.

"The technology could be paradigm-shifting in that we're really talking about a population that's very difficult to treat," said Lunning. "(These patients) have broken through our standard lines of chemotherapy and this isn't chemotherapy. This is your own body fighting off cancer. I think that this will reach an unmet need population within this country and I hope that not only does it take hold in this country, but globally."

Lunning said if the FDA approves this therapy, patients at Nebraska Medicine would benefit from it. He said with the Buffett Cancer Center, Nebraska Medicine is on track to be a leader for CAR T-Cell therapy.

If the FDA approves CAR T-Cell therapy for ALL leukemia patients that are either children or young adults, "We will be able to reach into the adult or young adult population if that approval does come from the FDA," Lunning said.

A similar trial for adults with ALL, in which Belohlavy participated, took place at Nebraska Medicine. It has since ended.

Nebraska Medicine is currently involved in a CAR T-Cell clinical trial for non-Hodgkin's lymphoma. Nationwide, the trial has had a 60 percent remission rate after 30 days and a 40 percent remission rate after 60 days.

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FDA panel endorses cancer therapy performed in clinical trials at Nebraska Medicine - KETV Omaha

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