Janssen presenta all'EMA l'estensione dell'indicazione per Carvykti (cilta-cel) nel trattamento in 2L del mieloma multiplo (2L r/r MM)

Janssen has announced the submission of Carvykti (cilta-cel) extension of indication to the EMA to include the treatment of adult patients with relapsed and lenalidomide-refractory (r/r) multiple myeloma (MM). 

The submission is based on data from the CARTITUDE-4 study (NCT04181827), a randomised Phase 3 study evaluating the efficacy and safety profile of ciltacel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.

Carvykti is currently approved in the EU with the following indication: 

"Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.".

Reference link: Janssen press release