FDA Committee Votes in Favor of B-Cell Acute Lymphoblastic Leukemia Drug

Gene therapy could be used to get rid of leukemia cells

The immunotherapy works by genetically alters a patient's own cells to fight cancer and bolsters the immune system to shut down the disease. "If approved, it will be the first-ever true gene therapy treatment made available to the United States population and will help accelerate the speed at which we will see even more gene-based therapies come to fruition". Advisory panel recommendations are not binding on the FDA but the agency typically adheres to what the group urges.

"This is a major advance and is ushering in a new era", said committee member Malcolm A Smith, who is associate branch chief for paediatric oncology at the National Cancer Institute in Bethesda, Maryland.

Researchers at the University of Pennsylvania developed the treatment, which is now licensed to Novartis. The cells would need to be frozen again and shipped back to the treatment centre. In 2015, the company acquired a cell manufacturing facility in Morris Plains, New Jersey, and a year ago it said it plans to develop centers in Europe and Japan.

The complication doesn't apply universally across all CAR-T products, and newer generations now in development appear able to avoid the permanent destruction of B cells. The ruling on the use of the CAR-T gene therapy will be announced by the end of September. The turnaround time for manufacturing the therapy, called "vein-to-vein" time, will be an estimated 22 days, Novartis officials told the committee Wednesday. The cells would be altered to seek out the cancer and attack it.

"The therapy is being given to people who would be dead if they didn't receive it, and they would be dead within a pretty short period of time", said Edmund Waller, director of Emory University's stem cell and immune therapy division.

The panel recommended approving it for B-cell acute lymphoblastic leukemia that has resisted treatment, or relapsed, in patients aged 3 to 25.

More than 600 patients in the USA each year reach that critical stage.

In a test conducted, gene therapy results exceeded chemotherapy, and even newer types of cancer medicines.

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In a clinical trial involving 63 patients with acute lymphoblastic leukemia, 83 percent went into remission following CART-T cell treatment.

Others had high praise for the drug's marketer, Novartis (NYSE: NVS), and its plans to keep a close eye on the potentially severe side effects of CAR-T if it becomes a commercial product.

"This is the beginning of something big", she added.

Photo Emily Whitehead, 12, with her parents Tom and Kari Whitehead, on Tuesday in Washington, D.C. The family appeared at a hearing for the F.D.A. about a new treatment for leukemia. She nearly died as a result of leukemia, which was considered fatal until she was treated at age 6. Five years later, Emily stood beside her father at the adcom as living proof that CTL-019 can work.

During the patient testing, the whole process took about 16 weeks on average, which can be too long a wait for some desperately ill patients, the FDA advisers noted during the meeting in Silver Spring, Maryland. Of 68 young people receiving it, 52 of them had an excellent response nearly immediately, with their cancer disappearing within the first three months. "This is an entirely new way of treating cancer and I think these cellular therapies are only in their first chapter".

By modifying immune cell DNA, this method could, in theory, lead to other cancers - a longtime concern for gene therapy.

A treatment for head and neck cancer in China was approved in 2004. A year later, two-thirds remained so.

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