Revolutionary Gene Therapy Treatment For Cancer Gets Approval In The USA

Novartis won FDA approval for its CAR-T drug Kymriah on Wednesday

The country's first approved gene therapy-approved Wednesday to fight leukemia that resists standard therapies-will cost $475,000 for a one-time treatment, its manufacturer announced.

The U.S. Food and Drug Administration (FDA) has approved the nation's first cancer gene therapy drug, which received its initial funding from Stamford-based Alliance for Cancer Gene Therapy (ACGT). Truly today's approval of the gene therapy by FDA is a milestone in the treatment of leukemia and it is expected that treatment becomes successful on long term basis. The patient was nearing death, but has now been cancer-free for five years. Novartis estimates about 600 patients a year would be eligible for the treatment, which belongs to a class of drugs known as auto T-cell therapies. It involves removing disease-fighting T cells from a patient, genetically modifying them to better recognize and attack cancer, and then replacing them, where they can circulate for years seeking out the disease.

Mitchell said the campaign group thought a price below $300,000 was more appropriate, but said the estimate came with a "huge disclaimer" because Novartis has not shared information about its costs.

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

Kymriah has a $475,000 price tag; however, patients who do not respond within a month of treatment will not be charged, according to Novartis. The company is carefully training hospitals and staff to provide the treatment, which can cause a life-threatening immune reaction, as well as long-term complications.

"The therapy", STAT reports, "is made by harvesting patients' white blood cells and rewiring them to home in on tumors".

The FDA said it has granted 76 applications for trials involving experimental CAR-T therapies.

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"Patients who get this therapy basically have no chance to survive", Satwani said. It would use gene therapy techniques to charge T cells where researchers can filter those cells from a patient's blood and reprogram it to cancel cancer and grow to millions of copies.

Cooper said fewer inpatient and outpatient visits for treatment and fewer hospitalizations are likely to result from treatment with vehicle 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". Penn and Novartis are also investigating the next generation of vehicle therapies for multiple myeloma, and for solid tumors, through trials in glioblastoma, mesothelioma, and ovarian and pancreatic cancer.

"In the next few years", he said, "I think we're going to see dramatic progress and push the boundaries of what many people thought was possible with these adoptive cell transfer-based treatments".

Health officials in the United States have approved a revolutionary treatment that uses genetic engineering to combat childhood leukemia.

Other drugmakers have been developing Car-T products, including Kite Pharma, which was snapped up for $11.9 billionby Gilead Sciences earlier this week.

Over the last few years, CAR-T cell research has exploded, and there are now nearly 300 clinical trials underway experimenting with the treatment.

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