Cassandra Willyard in Nature:
US drug regulators dropped a bombshell in November 2023 when they announced an investigation into one of the most celebrated cancer treatments to emerge in decades. The US Food and Drug Administration (FDA) said it was looking at whether a strategy that involves engineering a person’s immune cells to kill cancer was leading to new malignancies in people who had been treated with it.
Bruce Levine, an immunologist at the University of Pennsylvania Perelman School of Medicine in Philadelphia who helped to pioneer the approach known as chimeric antigen receptor (CAR) T-cell therapy, says he didn’t hear the news until a reporter asked him for comments on the FDA’s announcement.
“Better get smart about it quick,” he remembers thinking. Although the information provided by the FDA was thin at the time, the agency told reporters that it had observed 20 cases in which immune-cell cancers known as lymphomas had developed in people treated with CAR T cells. Levine, who is a co-inventor of Kymriah, the first CAR-T-cell therapy to be approved, started jotting down questions. Who were these patients? How many were there? And what other drugs had they received before having CAR-T-cell therapy?
More here.