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As a newer type of immunotherapy that’s used in cancer treatment, CAR-T or chimeric antigen T-cell therapy is a type of adoptive cell transfer designed specifically for individual patients. A patient’s immune system cells are reprogrammed to target their cancer. Approved by the FDA in 2017, it works by helping T-cells to recognize cancer cells, allowing the patient’s own body to go after the cancer cells.
To do this, the patient’s existing T-cells are collected, they are genetically engineered into CAR-T cells, the patient has a chemotherapy treatment, then their adapted CAR-T cells are injected back into the patient’s bloodstream, during which time the patient is carefully monitored either in the hospital or a nearby residential facility for two weeks, with patients staying within an hour’s drive of the center where they were treated for two additional weeks in case of complications.
Uses and Potential Side Effects of CAR-T Therapy
It specifically treats some children with leukemia and some adults with lymphoma, and clinical trials are ongoing for other types of cancer. However, there are very specific limitations on when the therapy can be used, due to the relative newness of the technology. For this reason, there are also a few side effects that you should be aware of when undergoing this type of therapy.
These include neurological changes, cytokine-release syndrome, allergic reactions, increased infection risk, and potential for high uric acid levels in the blood. This last is caused as the cancer cells are broken down quickly under the higher level of action by the CAR-T cells, which overwhelms the kidneys and increases the level of this compound in the blood.
What’s the Cost of CAR-T Therapy?
There is a range of different manufacturers for CAR-T therapies, which results in a range of different costs. As an example, Kymriah’s therapy runs very high, at approximately $475,000, while Yescarta’s therapy is at the low end of the list, at an affordable $373.00. It’s expected that these costs will continue to shift as more CAR-T therapies receive FDA approval and enter the market.
What Can We Expect from CAR-T Therapy in the Future?
With the rapid development of medical technologies with digital transformation, CAR-T techniques have developed rapidly, but it still has its challenges. Obtaining patient samples can be time-consuming, difficult, and expensive, so a shift from autologous to allogeneic therapies has begun. Manufacturers are being pressured to reduce manufacturing times, so reducing the time to reduce testing is vital, because this testing adds to the time needed for manufacturing and release the therapy for the patient’s use, which can double the time needed.
Originally begun in academia, CAR-T production is now moving into commercial production, with manufacturers needing to scale up to meet demand. As new approvals are granted and new patient populations are added, large-scale CAR-T production must continue quality control testing. With the advent of technological advancement, adaptation of the regulatory framework and approval of new therapies, CAR-T will continue evolving, with combination therapies helping to improve costing during production. Different antigen targets or precisely-selected T-cells or new transduction methods may change quality control testing methods.
As manufacturers work with regulators to define and specify quality control testing options for individual therapies, regulators are also putting more effort into delivering detailed guidance on release tests that are needed at every phase of the clinical trials and production. Technology developers are also working to improve standardization, production pace and overall costs of CAR-T therapies while ramping up for regulatory approval.
