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本帖最后由 StephenW 于 2017-7-13 08:49 编辑
CBS/AP July 12, 2017, 4:54 PM
CAR-T gene therapy for leukemia clears FDA hurdle  In this photo taken March 21, 2017, a nurse reaches for blood samples taken from a patient receiving a kind of immunotherapy known as CAR-T cell therapy at the Fred Hutchinson Cancer Research Center in Seattle.
Elaine Thompson / AP
A panel of cancer experts has voted in favor of a leukemia treatment which could be the first gene therapy available in the U.S.
The Food and Drug Administration advisory panel voted 10-0 on Wednesday to recommend approval of the treatment developed by the University of Pennsylvania and Novartis Corp. The one-time treatment would be for children and young adults with advanced leukemia.
The therapy could be the first of a wave of treatments custom-made to target a patient's cancer. Called CAR-T, it involves removing immune cells from a patients' blood, reprogramming them to create an army of cells to recognize and destroy cancer and injecting them back into the patient.
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FDA panel to vote on revolutionary gene therapy for cancer
The FDA is not required to follow the panel's recommendation but often does.
"It's a pretty amazing new treatment," Dr. David Agus, director of the USC Norris Westside Cancer Center and CBS News medical contributor, said on "CBS This Morning." "They take the white [blood] cells out of a child with cancer, they send them to [a lab in] New Jersey, and they put in a gene to reprogram these cells to attack the cancer."
In a clinical trial involving 63 patients with acute lymphoblastic leukemia, 83 percent went into remission following CART-T cell treatment.
Currently available only in studies at major cancer centers, the first CAR-T cell therapies for a few blood cancers could hit the market later this year. In addition to the University of Pennsylvania and Novartis treatment considered today, the FDA is also evaluating a version developed by the National Cancer Institute and licensed to Kite Pharma.
In March, CBS News chief medical correspondent Dr. Jon LaPook reported on the results of another clinical trial in which 101 patients with advanced lymphoma who had failed previous therapy and were treated with CAR-T. About eight months after a single treatment, 39 percent of patients had no evidence of cancer.
"That's actually quite remarkable knowing that at best only one out of 10 of these patients could have complete disappearance of their lymphoma with standard chemotherapy," said Dr. Frederick Locke, who helped lead the trial of the Kite Pharma treatment.
© 2017 CBS Interactive Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.
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发表于 2017-7-13 08:48