Gilead Sciences, Inc. (GILD)

US FDA mandates label updates on CAR-T cancer therapies

The U.S. Food and Drug Administration said on Thursday cancer therapies that use CAR-T technology will require changes to the so-called "boxed warning" to highlight the serious risk of T-cell blood cancer in patients who use these therapies. The health regulor has required related updates to other sections of the label such as warnings and precautions, postmarketing experience, patient counseling information and medication guide. In January, the FDA asked a host of drugmakers including Gilead Sciences, Johnson & Johnson and Novartis to add a boxed warning to their CAR-T cancer therapies, as it received reports of patients developing a type of T-cell blood cancer after being treated with them.