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FDA Advisers' Leukemia Treatment Approval Advances Gene Therapy

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By    |   Thursday, 13 Jul 2017 12:32 PM

The FDA's Oncologic Drugs Advisory Committee's recommendation of a leukemia treatment using gene therapy could be a boon to supporters of the technology, Dr. Carl June, leader of the experimental therapy, said in a statement Wednesday.

The FDA's Oncologic Drugs Advisory committee voted 10-0 Wednesday to approve the treatment, which was devised by the University of Pennsylvania and Novartis Corp., Fox News reported.

The Alliance for Cancer Gene Therapy supported the Novartis' experimental CAR-T therapy called Tisagenlecleucel, or CTL019, a statement from the alliance noted.

"The funds from ACGT sustained us," said June, of the University of Pennsylvania who was the leader in developing CTL019 therapy and pioneering the concept of using a patient's own T cells and genetically modify them to attack the cancer cells, according to the ACGT statement.

"When other organizations, including the (National Institutes of Health), considered gene therapy too risky, ACGT believed in the science and funded us when no one else would. ACGT really kept us going and kept the research alive. Without them, we wouldn't have had a clinical trial and I don't think we’d be where we are today," June continued.

The recommended therapy could be the first of a stream of treatments custom-made to target a patient's cancer, Fox News noted. The new treatment allows reprogrammed T cells to create an army of cells that can recognize and destroy cancer after injecting them back into the patient.

"This is a major advance," Dr. Malcolm A. Smith of the National Cancer Institute, told Fox News, saying that the treatment was "ushering in a new era."

Novartis said in its statement Thursday that it plans additional filings for CTL019 in the United States and the European Union later this year, including applications with the FDA and European Medicines Agency for the treatment of adults. The drug maker cautioned that more work is needed.

"Because CTL019 is an investigational therapy, the safety and efficacy profile has not yet been established," the Novartis statement said. "Access to investigational therapies is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the therapy. Because of the uncertainty of clinical trials, there is no guarantee that CTL019 will ever be commercially available anywhere in the world."

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The FDA's Oncologic Drugs Advisory Committee's recommendation of a leukemia treatment using gene therapy could be a boon to supporters of the technology, Dr. Carl June, leader of the experimental therapy, said in a statement Wednesday.
fad, leukemia, treatment, gene therapy
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2017-32-13
Thursday, 13 Jul 2017 12:32 PM
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