Carvykti first BCMA-targeted treatment approved by EC

The European Commission (EC) has approved a Type II variation for Carvykti (ciltacabtagene autoleucel; cilta-cel).

US healthcare giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag said this latest approval is for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM), who have received at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.1

The EC also today approved the conversion of the conditional marketing authorization (MA) for cilta-cel to a standard MA, as the obligations of the conditional approval have now been met.