Timely added approval for J&J’s Carvykti

The US Food and Drug Administration (FDA) has approved Johnson & Johnson (NYSE: JNJ) and Legend Biotech’s (Nasdaq: LEGN) Carvykti (ciltacabtagene autoleucel) in a new indication.

This approval is for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.

"We have been making considerable progress in increasing supply and availability in anticipation of this milestone approval"Previously, Carvykti was approved as a fifth-line treatment. This new approval makes it the first B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.