In a significant development, the FDA is set to impose a classwide black box warning following its investigation into secondary T-cell cancers arising from the use of existing CAR-T therapies. In its January 19 notification letters, the agency stressed that the potential risk applies to all currently approved CAR-T products. The regulatory body has mandated label updates for all six commercial CAR-T therapies, including those of major players such as Bristol Myers Squibb & Co BMY, Gilead Sciences Inc's Kite Pharma GILD, Johnson & Johnson JNJ, and Novartis AG NVS.