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Novartis gene therapy approval signals new cancer treatment era

Novartis gene therapy approval signals new cancer treatment era

The Food and Drug Administration approved a treatment called Kymriah.

The first cancer drug approved by USA regulators to use a patient's own cells to fight common childhood cancers is priced at a whopping $475,000.

"Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease", Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. About 85% of children who were treated with Kymriah achieved remission for five years, if not longer. Novartis came up with the gene therapy with the University of Pennsylvania.

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

The FDA granted approval of Kymriah to Novartis Pharmaceuticals Corp. The new treatment can act as a lifesaver for those patients who did not recover through first line drug treatments.

Novartis will create a registry to follow patients for 15 years after being treated to monitor their progress and any potential, future side effects. After being infused back into patients' bodies, these newly built "hunter" cells both multiply and attack, targeting cells that express a protein called CD19.

The FDA said it has granted 76 applications for trials involving experimental CAR-T therapies. Novartis also considered the cost of bone-marrow transplants, which are now given to many leukemia patients whose cancer relapses.

Cooper said fewer inpatient and outpatient visits for treatment and fewer hospitalizations are likely to result from treatment with auto T-cell therapy, which he said would allow parents and other family members and caregivers "to resume a normal life, including the possibility to return to work".

The FDA's move to approve the vehicle T-cell therapy, which will be marketed under the name "Kymriah" by Novartis Pharmaceuticals, opens the door to a new era of cancer medicine, and medicine more broadly. Eventually, the therapy will be offered at 32 sites, the company said. The engineered T-cells can lead to what is called cytokine release syndrome, a life-threatening condition that is triggered by an overactive immune system.

Most patients with ALL recover through other treatments such as radiation, chemotherapy and stem cells.

Epstein said he envisioned cell therapies having much shorter life cycles than traditional drugs.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices.

Kymriah is the first CAR-T cell therapy to get approved, and there are several more in the works. Instead of getting a better, updated therapy for a disease every decade or so, we might begin to see second-generation cell therapies in a few years.

There could be side effects.

Based on available data, patients on the treatment have had an 89% chance of surviving at least six months and a 79% chance of surviving at least a year, with most being relapse-free at that point.

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