Approval provides another step forward in transforming multiple myeloma outcomes and eliminating the disease

The European Commission (EC) has approved Janssen’s CAR-T therapy, Carvykti, for adults with heavily pre-treated, relapsed and refractory multiple myeloma, marking the treatment’s first approval outside of the US.

Carvykti – also known as ciltacabtagene autoleucel or cilta-cel – has been approved for adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies. The patients should also have demonstrated disease progression on the last therapy.

As a one-time treatment, the milestone approval provides physicians with an immunotherapy option that offers patients an opportunity to be free from anti-myeloma therapies for a potentially considerable period of time.

It represents another step forward in transforming multiple myeloma outcomes, moving closer towards the ultimate goal of one day eliminating the disease.

Carvykti is a chimeric antigen receptor therapy, featuring two B-cell maturation antigen targeting single domain antibodies, which are specifically developed for each individual patient and administered as a single infusion.

This approval was further supported by the pivotal CARTITUDE-1 study, which included patients who had received an average of six prior treatment regimens and had previously received an anti-CD38 monoclonal antibody.

The findings were presented at the American Society of Clinical Oncology 2021 Annual Meeting. It was announced that 98% of patients with RRMM responded to therapy, while 80% of patients achieved a stringent complete response – a measure in which a physician is unable to observe any signs or symptoms of disease via imaging or other tests after treatment.

“Patients who have relapsed, or for whom treatment regimens have stopped working after experiencing the three major drug classes, typically face poor survival. Despite recent innovation, new therapeutic approaches are still needed,” explained Maria-Victoria Mateos, consultant physician in haematology at University Hospital of Salamanca.

“The CARTITUDE-1 data, on which the EC approval is based, show that a single infusion of cilta-cel resulted in durable responses in a heavily pre-treated patient population. These results support the potential of cilta-cel in offering patients and physicians a valuable new treatment option,” she added.