FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy

Novartis dodged deaths from its CAR-T Therapy, but FDA still has safety concerns

"The Leukemia & Lymphoma Society (LLS) applauds today's unanimous decision of the FDA advisory panel on Novartis' CAR-T immunotherapy, which marks a significant breakthrough for cancer patients", the LLS stated in a press release. The FDA is not bound by the decisions of its advisory committees but follows the recommendations more often than not.

"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. But unlike traditional gene therapy, the new treatment doesn't replace disease-causing genes with healthy ones. In the United States, about 15% of children and young adults with acute leukaemia relapse following treatment.

"We believe that when this treatment is approved, it will save thousands of children's lives around the world", Emily's father, Tom Whitehead, told the panel. It affects only 5,000 people a year, about 60 percent of them children and young adults.

The recommendation of ODAC was based on the evaluation of the CTL019 r/r B-cell ALL development program that included the firm-lead ELIANA study, which is claimed to be the first pediatric global CAR-T cell therapy registration trial.

The FDA is expected to decide whether to approve the Novartis treatment in the next few months.

The immune system-altering treatment is for patients aged 3 to 25 with a blood cancer called acute lymphoblastic leukemia (ALL) - the most common form of childhood cancer in the US. That happens to more than 600 patients in the USA each year. An approval decision for the Kite CAR-T is expected on November 29.

In a key test, results were far better than chemotherapy and even newer types of cancer drugs. And the cost of treating each patient for a lifetime is expected to increase 310 percent, to $604,000 from $147,000 during that same period.

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.

Women-free shrine Okinoshima gets world heritage status from Unesco
Okinoshima island is home to an ancient religious site built in the 17th century and has three small sacred Shinto shrines. The land is owned by Munakata Taisha, and it is a criminal offense to visit the island without the shrine's permission.

The main side effect of CTL-019 is cytokine release syndrome, a blistering immune reaction to the drug and the detritus of dying cancer cells. During the process, T cells are drawn from a patient's blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient's cancer cells and other B-cells expressing a particular antigen.

But the M.D. Anderson approach did present one big challenge: NK cells don't persist in the body for more than two or three weeks, limiting their potential utility as cancer treatments.

Treatment with CTL019 involves removing some blood from the patient and modifying the T-cells in the blood before the cells are returned into the body.

The approval of the drug is likely, especially in light of the positive results of experiments in the field of cell modification to fight diseases. The whole testing process took 16 weeks on average, which FDA advisers noted could be too long for severely ill patients.

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

"I am amused by the horse-race metaphors that are used to frame the various companies developing CAR-T therapies".

Novartis has confirmed it will file for approval of the cell therapy later this year in the European Union, where it became one of the therapies to enter the EMA's new PRIME expedited approval pathway.


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