Twenty-five reports of rare blood cancers in patients who had received CAR T-cell therapy prompted agency’s warning<\/p>\n<\/h3>\n
By Physician\u2019s Briefing Staff HealthDay Reporter<\/b><\/p>\n
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WEDNESDAY, Jan. 24, 2024 (HealthDay News) — Citing recent indications that CAR T-cell therapy may cause rare secondary cancers, the U.S. Food and Drug Administration has told pharmaceutical companies to add a boxed warning<\/a> to their products.<\/p>\n However, FDA spokesperson Carly Kempler told NBC News<\/em> that despite the new warning, “the overall benefits of these products continue to outweigh their potential risks.” Twenty-five reports of rare blood cancers in patients who had received CAR T-cell therapy prompted the agency to add the boxed warning, Kempler said.<\/p>\n In 2017, the first CAR T-cell therapy, Novartis drug Kymriah<\/a>, was approved by the FDA. Additional therapies have since been approved. The makers of five of these drugs — Bristol Myers Squibb, for Abecma and Breyanzi; Gilead Sciences’ Kite Pharma, for Yescarta; Johnson & Johnson’s Carvykti; and Novartis, for Kymriah — must submit proposed label changes in the next 30 days to note that CAR T-cell therapy can raise the risk for rare blood cancers, the FDA said. If the drugmakers disagree, they can submit a rebuttal explaining why a change is not needed, NBC News<\/em> reported.<\/p>\n In a statement, a spokesperson for Novartis said the company has not found “sufficient evidence” to support a link between cancer and its treatment. However, the company will work with the FDA to update its label “appropriately,” the spokesman said. Spokespersons for Johnson & Johnson and Gilead Sciences also told NBC News<\/em> that they would work with the agency to update their labels. A spokesperson for Bristol Myers Squibb said the company is evaluating “next steps” following the FDA notice, although it has not seen any cancer cases associated with its treatment.<\/p>\n CAR T-cell treatments are still relatively new, so the FDA has required<\/a> the makers of these therapies to conduct 15-year follow-up studies to measure the potential risk for secondary cancers.<\/p>\n The FDA “is not saying that every single one of the cases they’ve reported has clearly shown CAR T has led to this, but more that there may be an association,” Matthew Frigault, M.D., clinical director of the Massachusetts General Hospital Cellular Immunotherapy Program in Boston, told NBC News<\/em>. “This is what the FDA does. They look for a signal.”<\/p>\n