A recent investigation by the Food and Drug Administration (FDA) has revealed a concerning possibility: CAR-T therapies, which have been hailed as a breakthrough in treating terminal blood cancers, may inadvertently lead to the development of new cancers in patients undergoing the treatment.
CAR-T therapy involves extracting immune cells from a patient’s body, modifying them to target tumors, and then reintroducing them into the patient’s bloodstream. While this treatment has been credited with saving the lives of many patients since its approval in 2017, there are now reports linking it to 19 cases of new cancer.
The therapy works by genetically engineering T cells to produce chimeric antigen receptors (CARs), which enable them to recognize and attack cancer cells. However, there’s a concern that this process could disrupt cell DNA and potentially lead to the development of other cancers, although this risk is considered small.
The FDA emphasizes that the number of reported cases is minimal compared to the number of lives saved by CAR-T therapy. Despite this potential risk, the overall benefit of the treatment still outweighs the potential harm.
It’s not uncommon for cancer treatments, such as radiation and chemotherapy, to carry a small risk of triggering new cancers. However, the FDA will be investigating further to assess the risk associated specifically with CAR-T therapy and evaluate the need for regulatory action.
As part of ongoing monitoring, patients receiving CAR-T therapy, either as approved treatment or as part of a clinical trial, will be closely monitored for life for the development of new malignancies. The FDA advises healthcare providers to promptly contact the therapy’s manufacturer if a new cancer arises in a patient undergoing CAR-T treatment.
Several pharmaceutical companies, including Gilead Sciences, Johnson & Johnson, Bristol Myers Squibb, and Novartis, have developed approved CAR-T therapies. Gilead Sciences, in particular, has stated that it is cooperating with the FDA’s request for data analysis and maintains confidence in the safety profile of its CAR-T therapies, Tecartus and Yescarta.
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