NVS - Focus On Bristol Myers Gilead Sciences Johnson & Johnson Novartis: FDA To Issue Classwide Black Box Warning on CAR-T Therapies For Blood Cancer Treatment | Benzinga
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 (NYSE:BMY), Gilead Sciences Inc’s Kite Pharma (NASDAQ:GILD), Johnson & Johnson (NYSE:JNJ), and Novartis AG (NYSE:NVS). This move places T-cell malignancies in the boxed warning section, the most severe safety alert on a medication’s label.
The affected products include Bristol’s Abecma and