European Commission Conditionally Approves Janssen and Legend Biotech’s Carvykti for Multiple Myeloma

The European Commission has given conditional approval to Janssen’s chimeric antigen receptor (CAR) T-cell therapy Carvykti (ciltacabtagene autoleucel) for relapsed and refractory multiple myeloma patients who have been on at least three prior therapies.

The conditional marketing authorization was based on study results showing that 98 percent of participants responded to treatment and 80 percent of patients saw a stringent complete response, the latter meaning physicians saw no signs or symptoms of disease using imaging and other tests after treatment.

Carvykti is the result of an exclusive collaboration and global licensing agreement between Janssen and Legend Biotech, a deal that was inked in December 2017.

Though the drug was granted FDA approval in February 2022, it was given only through a Risk Evaluation and Mitigation Strategy program due to risks of cytokine release syndrome and nervous system toxicities.