FDA Receives Supplemental BLA for Ciltacabtagene Autoleucel

The US Food and Drug Administration (FDA) has received a supplemental Biologics License Application (BLA) for ciltacabtagene autoleucel that seeks to expand its label to include the treatment of adults with relapsed and lenalidomide-refractory multiple myeloma (MM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.

“This submission brings us one step closer to potentially helping more patients facing relapsed and refractory multiple myeloma, as we continue to explore the potential of CARVYKTI® in earlier lines of treatment,” Legend Biotech Chief Executive Officer Ying Huang, PhD, said in a news release. “The prospect of bringing this vital treatment option to more patients excites us, and we remain committed to working with the US FDA and our partner, Janssen, to help patients with multiple myeloma around the world.”

The supplemental BLA submission is supported by data from the CARTITUDE-4 study. It was an international, randomized, open-label phase III study evaluating the efficacy and safety of ciltacabtagene autoleucel. The study compared ciltacabtagene autoleucel with standard-of-care regimens in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.

Source: PR Newswire, June 2023