By Heidi Ledford
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.
Novartis is seeking approval to use tisagenlecleucel to treat children and young adults who have a form of leukaemia called acute B-cell lymphoblastic leukaemia, and who have not responded sufficiently to previous treatment or have relapsed since that treatment. In the United States, about 15% of children and young adults with acute lymphoblastic leukaemia relapse.
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