FDA has approved idecabtagene vicleuce (Abecma—Celgene), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. It is the first cell-based gene therapy approved by FDA for the treatment of multiple myeloma. “The FDA remains committed to advancing novel treatment options for areas of unmet patient need,” said Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research. “While there is no cure for multiple myeloma, the long-term outlook can vary based on the individual's age and the stage of the condition at the time of diagnosis. Today's approval provides a new treatment option for patients who have this uncommon type of cancer.” Each dose of idecabtagene vicleuce—a B-cell maturation antigen-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy—is a customized treatment created by using a patient's own T-cells, which are a type of white blood cell, to help fight the myeloma. The patient's T-cells are collected and genetically modified to include a new gene that facilitates targeting and killing myeloma cells. Once the cells are modified, they are infused back into the patient. FDA is requiring that hospitals and their associated clinics that dispense be specially certified and staff involved in the prescribing, dispensing or administering of idecabtagene vicleuce are trained to recognize and manage CRS and nervous system toxicities and other adverse events of the therapy.