First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma Approved
The U.S. Food and Drug Administration (FDA) announced the approval of Abecma (idecabtagene vicleucel), 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.
Abecma is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma.
“The FDA remains committed to advancing novel treatment options for areas of unmet patient need,” commented Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press statement issued on March 27, 2021.
“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.”
Multiple myeloma is an uncommon type of blood cancer in which abnormal plasma cells build up in the bone marrow and form tumors in many bones of the body. This disease keeps the bone marrow from making enough healthy blood cells, resulting in low blood counts, says the FDA.