In historic first, FDA approves Novartis CAR-T therapy

A child is seen in a hospital in this undated file

US clears first 'living drug' for childhood leukaemia

T-cells, which are a type of white blood cell, are removed from an individual patient and sent to a manufacturing center where they are genetically programmed to target leukemia cells that have a specific marker.

The immunotherapy now can be used in children and young adults with B-cell ALL that will not respond to other therapies, the FDA announced. Tisagenlecleucel (Kymriah) is a personalized genetically-modified autologous T cell immunotherapy created to use a patient's own T cells to target and kill leukemia cells with CD19 antigens on the surface, according to a press release.

"Through our collaboration with Novartis, we are creating the next wave of immunocellular cancer treatments, and are eager to progress CAR-T therapy in a host of hematologic and other cancer types", said Carl June, MD, Professor of Immunotherapy, Director of the Center for Cellular Immunotherapies in Penn's Perelman School of Medicine.

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Kymriah, a cell-based gene therapy, is approved in the United States for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse. Less than 10 percent of patients with the most common form of ALL survive longer than five years under current treatment regimens, Novartis said.

The National Cancer Institute estimates 3,100 patients are diagnosed each year with ALL, which can come in several forms. Kymriah handles this turbocharging within the patients body.

It's too soon to tell how widely applicable CAR-T will be - it's especially suited to leukemia since infusing patients with T-cells is relatively simple.

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The drug has shown promising remission and survival rates in clinical trials, the FDA said. However, there were some severe side effects observed in study. Tisagenlecleucel carries a boxed warning for cytokine release syndrome (CRS) and neurological events, which can be life threatening. The price is well below the $700,000 that was estimated before the approval of the drug. Researchers hope that this will lead to further CAR-T treatments that can fight more complicated cancers such as pancreatic, breast, and brain cancer.

Novartis plans additional filings for Kymriah in the US and EU later this year, including applications with the FDA and European Medicines Agency, for the treatment of adult patients with r/r diffuse large B-cell lymphoma (DLBCL).

For more on childhood acute lymphoblastic leukemia, visit the U.S.

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