Novartis claims first CAR-T approval, setting $475k price tag

Novartis' CAR-T gene therapy, the first approved by FDA, to be priced based on cancer patients' outcomes

The patient's T-cells (a type of white blood cell) are shipped off to a lab where they are genetically redesigned to include a new gene that contains a specific protein.

While that's a one-time process, it's not the end of the road.

"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", Food and Drug Administration Commissioner Scott Gottlieb said in a statement. "It's a great accomplishment". This is the first gene therapy of its kind to be approved for use in the United States, but the treatment is not without controversy as it has the potential for severe side effects as well as an extraordinarily prohibitive price tag.

"This transformational therapy for patients is the result of true collaboration between industry, academia, healthcare professionals, patients and caregivers", said Bruno Strigini, CEO, Novartis Oncology.

The trial was successful, with 83% of the 63 clinical patients treated for relapsed or refractory B-cell undergoing successful remission within three months of treatment. "Obviously this will change the lives of many patients and their families and the field". Whereas the time involved in processing is considered critical because of the need for rapid treatment of patients, Novartis has a cryogenic process that enables it to freeze and store samples of patients' blood cells for processing at more convenient times and earlier during the treatment cycle. Kite Pharma, Juno Therapeutics, and Bluebird Bio are among a growing group of biotech companies working with CAR-T. Novartis also considered the cost of bone-marrow transplants, which are now given to many leukemia patients whose cancer relapses.

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CAR-T cell therapy is indisputably a revolution in cancer treatment, but much more research needs to be done before it's labeled the breakthrough we've all been waiting for. The hope is that one day doctors might be able to prescribe a cell therapy and use it that same day, instead of waiting weeks to get the therapy back. However, ultimately, the cell therapy could go a long way in saving hundreds of young people's lives each year. 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. Instead of getting an updated therapy that works better on a disease every decade or so, we might begin to see second-generation cell therapies in just a few years.

Those updates could increase the number of patients that cell therapies can treat.

They'd also have to be less toxic so that more people could consider it, instead of only those who have very few other options. "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 haematologic and other cancer types".

The high cost of the therapy reflects the fact that the CAR-T procedure is fairly intensive.

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. Most symptoms appear within one to 22 days following infusion of Kymriah.

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