In historic first, FDA approves Novartis CAR-T therapy

Bryan Strickland
August 31, 2017

A chimeric antigen receptor (CAR) receptor is added to them, and the enhanced T-cells are then returned to the patient's blood stream, where they're newly capable of hunting down and destroying cancer cells. 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. Gilead shares jumped 5.5 percent on Wednesday as Kite is widely seen as likely to receive the next US approval of a CAR-T therapy.

The treatment was approved for certain children and young adult up to the age of 25 who suffer from a form of acute lymphoblastic leukemia (ALL) - a cancer of blood and bone marrow that is the most common childhood cancer in the United States.

While most survive, about 15% relapse despite the current best treatments, and their prognosis is bleak.

"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", FDA Commissioner Scott Gottlieb said in a news release following the approval.

About 3,100 patients 20 and younger are diagnosed with ALL each year, according to the U.S. National Cancer Institute. Kymriah handles this turbocharging within the patients body. It is caused by overactive genetically modified immune cells.

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He added: 'I did read, with the requisite attention, all the papers produced by Her Majesty's Government and none of those is actually satisfactory.

The drug has shown promising remission and survival rates in clinical trials, the FDA said.

Potential side effects of Kymriah include cytokine release syndrome, a bodily response characterized by high fever and flu-like symptoms.

However, Kymriah comes with the potential for severe side effects. In a trial of Kymriah, 83 percent of 63 patients with hard-to-treat disease were in remission within three months, according to Novartis. Kymriah's maker, Novartis, hasn't provided a price for 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. Research is therefore focusing for now on refining the therapy for patients of this disease.

Novartis had received a trifecta of designations that helped speed approval: the FDA gave fast-track, breakthrough therapy, and priority review status to tisagenlecleucel's application.

"The theory is they should attack the tumor and continue to grow to become a long-term monitoring and treatment system", Lichtenfeld said.

Other reports by GlobalViralNews

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