Health Care

FDA panel endorses first gene-altering therapy for leukemia patients

FDA panel endorses first gene-altering therapy for leukemia patients”

An FDA advisory committee voted unanimously in favor of the regulator approving Novartis' experimental CAR-T cell therapy, a move that signals the likely arrival of a dramatically new type of cancer treatment. Novartis is seeking approval to use the therapy on patients ages three to 25, particularly in patients who have failed to respond to standard treatments - something that occurs in over 600 people in the U.S. yearly.

Thomas Whitehead, whose daughter was the first pediatric patient to receive the treatment, choked up while telling panel members about Emily's experience. Called CAR-T, this treatment procedure involves taking out immune cells from a cancer patient's blood then "reprogramming" them to produce cells that can hone in and destroy cancer cells.

The FDA is not required to accept the recommendations of its advisory panel, but it usually does.

If cleared by the FDA, it would be the first gene therapy approved in the United States.

The concept, called CAR-T, was devised by the University of Pennsylvania and drug maker Novartis Corp. Novartis is seeking approval for use in children and young adults with leukemia who have relapsed despite undergoing chemotherapy. "This is an entirely new way of treating cancer and I think these cellular therapies are only in their first chapter".

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"While CAR-T is a promising new type of immunotherapy, it is not commercially available and we have yet to complete our evaluation", said T.J. Crawford, a spokesman for Aetna Inc.

Brody said personalized immunotherapy treatments like this one require that patients use their own immune cells because they would "almost never (find) a match" in an off-the-shelf product.

44 % of diagnoses were in children under 15 years of age. If it follows ODAC's advice, it will approve the world's first vehicle T therapy.

Patients with ALL who fail chemotherapy typically have a 16 to 30 percent chance of survival.

"It's a pretty wonderful new treatment", Dr. David Agus, director of the USC Norris Westside Cancer Center and CBS News medical contributor, said on "CBS This Morning".

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Novartis' risk mitigation also includes an education program for the sites providing the treatment and a registry, which the ODAC members and the FDA cited as essential to tracking long-term risks and better understanding of T cells.

"It's a new world, an exciting therapy", said Dr. Gwen Nichols, the chief medical officer of the Leukemia and Lymphoma Society, which paid for some of the research that led to the treatment. "CAR NK cells are scalable in a way that CAR T cells are not", she said.

But the drug has side effects that can be fatal, such as cytokine release syndrome or CRS, which "looks like sepsis" and causes blood pressure to drop dangerously low, said Diefenbach.

The drug supposedly works on making gene changes to enhance the patient's natural immune system and improve its ability to control disease.

In 2016, a Novartis exec told MM&M that the company plans to use a medical device-like sales model to market its CAR-T cell technology, which would rely more heavily on education for physicians than on detailing. Researchers also are exploring vehicle T-cell therapy's use for multiple myeloma and chronic lymphocytic leukemia, the disease that afflicted Ludwig.

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FDA reviewers said ahead of the meeting they were concerned about the potential for these viruses to infect patients and cause secondary cancers.



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