Despite a Food and Drug Administration warning this year, the risk of getting secondary blood cancer after receiving CAR T-cell therapy, a cell-based cancer treatment, is low, according to a Stanford Medicine study. How’s that? Of the 724 people treated with CAR T-cell therapy at Stanford Health Care between 2016 and 2024, roughly 6.5 percent developed secondary blood cancers within three years, researchers found, similar to secondary cancer rates seen among patients who receive stem cell transplant cancer treatments. Secondary cancer is when cancer cells spread, or metastasize, in the body. Why it matters: The FDA told several drugmakers in January to add a boxed label, the agency’s highest safety warning, to CAR T-cell therapy because of the therapy’s risk for triggering secondary cancers. The FDA did the right thing by issuing the warning, according to Dr. David Miklos, a co-author of the study and a professor of medicine and chief of bone marrow transplantation and cellular therapy at Stanford Health Care. “There is a lot of oversight occurring,” Miklos told Erin. “Doctors and the government are stewarding what is a relatively new therapy.” The FDA approved the first CAR T-cell therapies in 2017. Since the treatment is new, it’s important for researchers and the government to track its long-term safety by looking for warning signs that might occur one, five or even 10 years after treatment. “That work is being done,” Miklos said. The bottom line: The risk of developing second cancers pales in comparison to the risk of foregoing treatment. “Patients who are fortunate enough to get the therapy are then at risk for more risks,” Miklos said. “If you didn’t get the therapy, unfortunately, with this disease, you die — you die within three to six months.” The National Institutes of Health-backed research was published this month in The New England Journal of Medicine. The research was conducted at a single center, so outcomes might differ in another setting.
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