Engineered cell therapy for cancer gets thumbs up from FDA advisers
The benefits of cells used as CAR-T therapies (orange) make them attractive options for certain people with cancer.
External advisers to the US Food and Drug Administration (FDA) have thrown their support behind a therapy that genetically engineers a patient’s own immune cells to target and destroy cancers.
In a unanimous vote on 12 July, the panel determined that the benefits of CAR-T therapy outweigh its risks. The vote comes as the agency considers whether to issue its first approval of a CAR-T therapy, for a drug called tisagenlecleucel, manufactured by Novartis of Basel, Switzerland.
The FDA is not obligated to follow the recommendations of its advisers, but it often does.