BRIEF—Janssen files for new Carvykti indication in Europe

US healthcare giant Johnson & Johnson subsidiary Janssen has submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma.

The novel BCMA-directed T-cell therapy is being developed in partnership with Legend Biotech. Carvykti is playing catchup with Bristol Myers Squibb’s Abecma (idecabtagene vicleucel), the other product of this type on the market.

“The previous European Commission approval [in May last year] recognized the potential for cilta-cel to positively impact outcomes for people living with relapsed and refractory multiple myeloma,” said Edmond Chan, senior director, EMEA Therapeutic area lead hematology, Janssen-Cilag.

“Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy earlier in their treatment journey. If approved, this will be the first and only CAR-T therapy available to treat relapsed and refractory multiple myeloma patients as early as second line,” he added.