Cancer-killing drug approved, but will you be able to afford it?

"We're at the very beginning of what's going to be a big new field of medicine", said David Epstein, who helped license Kymriah from the University of Pennsylvania while at Novartis. The lab will preform genetic engineering using a virus and will have the cells multiply before freezing them and shipping back to the hospital, where they will be given to the patient via an IV.

"We're excited and proud to have moved this vehicle 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.

The drug was one of several CAR-T therapies rushing to be the first to market.

Scientists often refer to this type of gene therapy as a "living drug" because it involves using genetically modified immune cells from patients.

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To make sure patient safety is the priority, the FDA is requiring Novartis to offer the treatment only through medical centers that have been specially trained and certified.

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

Although the price of the therapy is high by any standard, Cooper stated that Novartis is "committed to doing everything we can to ensure that children and young adults who can benefit from [tisagenlecleucel] have access to the therapy and we are working with payers to ensure they fully understand the value of [it] and provide coverage for patients".

"Patients who get this therapy basically have no chance to survive", he said. The FDA says it provides a sorely needed treatment option for the disease. And a second, for adults with advanced lymphomas, may be close behind. More than 3.000 children are diagnosed with leukemia each year in the U.S and out of them, 155 relapse despite being given multiple treatments.

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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. It is individualized. T-lymphocytes, cells of the immune system of the patient, are collected, reprogrammed, cultured and frozen.

In July 2017, an FDA advisory panel unanimously recommended approval of the therapy, paving the way for today's FDA approval. More than half were children and teens. The treatment carries a boxed warning for cytokine release syndrome (CRS) and for neurological events. Patients were treated with the immunosuppressant drug tocilizumab or short courses of steroids to combat the symptoms.

However, this type of therapy carries risk of severe side effects.

"The efforts involved in being able to provide this novel therapy to patients is unlike any other therapy now offered", says Colleen Dansereau, MSN, RN and CPN, who is director of clinical research nursing and gene therapy program manager at Dana-Farber/Boston Children's.

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The Novartis-Penn Center for Advanced Cellular Therapeutics (CACT) opened in 2016 and hosted Vice President Joe Biden at the launch of his Cancer Moonshot initiative, cementing Penn's role as an worldwide innovator in the development and manufacturing of personalized cellular therapies.

(Copyright © 2015. All Rights Reserved.)
 
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