Novartis's new $475000 cancer drug among most expensive ever

Joy Montgomery
September 1, 2017

"This is the first-ever true gene therapy treatment made available to the U.S. population and will help accelerate the speed at which we will see even more gene-based therapies come to fruition".

The Food and Drug Administration has approved a new leukemia treatment that may bring hope to cancer patients, but it comes at a high price.

"We're excited and proud to have moved this auto therapy, in collaboration with Novartis and CHOP, through all phases of development and clinical trials, established its efficacy, and now extended its reach to children across the country under this FDA approval", he added. On Wednesday, FDA also expanded the approval of tocilizumab (Actemra-Genentech) to treat vehicle T-cell-induced severe or life-threatening CRS in patients aged 2 years or older.

"These are patients who have no prospect for long term disease control who get a single infusion of the cells and many of them remain in remission and require no other therapy, said Stephan Grupp, Professor of Pediatrics at 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 FDA Commissioner Scott Gottlieb, M.D. Mitchell said to The Guardian that he and his team met with Novartis the day before the drug's approval and price were to be announced, and he claims that the drug company "spent most of the meeting explaining why it needs to charge an astronomical price". 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. The T cells grow hundreds of millions of copies and fight back leukemia.

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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. However, Novartis also reported that tisagenlecleucel will cost nothing if patients do not benefit within 1 month of treatment.

The one-time treatment has a boxed warning for cytokine release syndrome or CRS, a life-threatening side effect that can cause blood pressure to drop dangerously low.

The CAR-T treatment is aimed to treat patients desperately ill with common pediatric cancer. The organisation forecasts that considerable investment will be made in the cell therapy field, particularly as there are other companies in the process of submitting applications to regulatory bodies for similar therapies. "The real question is going to come when this therapy is poised to be expanded into other patients who are older, and providing the chance for 60 or 70 years of [additional] life is not what you're talking about, and then we're really going to have some tough value questions that we should be prepared to ask".

Kymriah is expected to be available through a network of certified treatment centers throughout the United States. "It will be several years before cell therapies are widely accessible for patients in more indications beyond leukaemia and lymphoma", said Dr Miguel Forte, PhD, chief commercialization officer, ISCT and chief medical officer, Bone Therapeutics. 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.

For one, the treatments will have to treat more types of cancer than the one approved on Wednesday.

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