US FDA requires updates to labels for CAR-T cancer therapies, Health News on ET HealthWorld

The U.S. Food and Drug Administration has announced that cancer therapies using CAR-T technology will now require changes to their warning labels to highlight the serious risk of T-cell blood cancer in patients. This decision comes after reports of patients developing a type of T-cell blood cancer after receiving treatment with CAR-T therapies.

The FDA has mandated updates to various sections of the label, including warnings and precautions, postmarketing experience, patient counseling information, and medication guides. Patients and clinical trial participants receiving these therapies are advised to be monitored lifelong for secondary malignancies, and manufacturers should be notified in the event of a new malignancy.

Major drugmakers such as Gilead Sciences, Johnson & Johnson, and Novartis have been asked to add a boxed warning to their CAR-T cancer therapies. Some of the affected therapies include Bristol Myers Squibb’s Breyanzi and Abecma, J&J unit Janssen and Legend Biotech’s Carvykti, Novartis AG’s Kymriah, and Gilead unit Kite’s Tecartus and Yescarta.

The FDA’s decision underscores the importance of monitoring and reporting adverse effects associated with CAR-T therapies. Patients and healthcare providers should be vigilant in observing any signs of secondary malignancies and promptly informing manufacturers of any new developments. The agency’s proactive approach aims to ensure patient safety and minimize the risks associated with these innovative cancer treatments.