Cancer drug a major breakthrough - but it has a hefty price tag

The "historic action" by the Food and Drug Administration (FDA) permits a new treatment that uses a leukemia patient's own blood to engineer a method to attack the cancer. 5 years ago, for the first time, he used the CAR-T cell therapy to treat a girl child who was close to death but now she is completely ok.

"This is a turning point in the fight against B-cell ALL that opens up opportunities for patients across the world who desperately need new options", said Carl June, MD, the Richard W. Vague Professor in Immunotherapy in the department of Pathology and Laboratory Medicine in Penn's Perelman School of Medicine and director of the Center for Cellular Immunotherapies in the Abramson Cancer Center. "Novartis should not get credit for bringing a $475,000 drug to market and claiming they could have charged people a lot more".

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.

"Not only does Kymriah provide these patients with a new treatment option where very limited options existed, but a treatment option that has shown promising remission and survival rates in clinical trials". Nevertheless, researchers caution that, in many respects, it's still early days for vehicle T cells and other forms of ACT, including questions about whether they will ever be effective against solid tumors like breast and colorectal cancer. For others, Kymriah serves as a "bridge to transplant", keeping them alive longer enough to undergo this therapy.

The new treatment involves removing immune cells called T cells from a patient's blood and giving them a gene for a protein called a chimeric antigen receptor, or vehicle, that directs the T cells to target leukemia cells.

As with any drug, there are potential side effects, including cytokine release syndrome (CRS) and "neurological events", both severe and possibly life-threatening.

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"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.

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

"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. "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 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.

The treatment is the first of its kind approved in the U.S.

Other drugmakers have been developing Car-T products, including Kite Pharma, which was snapped up for $11.9 billionby Gilead Sciences earlier this week. The patient was a little girl nearly dying and is now five years cancer free.

(Copyright © 2015. All Rights Reserved.)
 
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