The FDA approved the chimeric antigen receptor T-cell therapy ciltacabtagene autoleucel, or cilta-cel, for the treatment of relapsed/refractory multiple myeloma (RRMM) in patients who have had four or more prior lines of therapy.
The approval of cilta-cel (Carvykti, Legend/Janssen) was based on results of the phase 1b/2 CARTITUDE-1 study, which showed a complete response in more than 80% of patients and a very good partial response in nearly all others.
“The median PFS [progression-free