Product research

J&J receives conditional CE approval for its first cell therapy product for multiple myeloma

The European Commission has granted conditional marketing authorization to Janssen Pharmaceutical Companies of Johnson & Johnson for CARVYKTI (ciltacabtagene autoleucel), a cell therapy for the treatment of multiple myeloma.

Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) has received conditional marketing authorization from the European Commission (EC) for CARVYKTI (ciltacabtagene autoleucel; cilta-cel), the company’s first cell therapy, according to a statement. press release of May 26, 2022. The therapy has been approved to treat adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior treatments, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody , and who demonstrated disease progression at the last treatment.

The conditional marketing authorization was based on a pivotal phase Ib-II study (CARTITUDE-1), in progress (1). The study includes patients who had received a median of six prior treatment regimens (range, three to 18) and had previously received IMiD, PI, and anti-CD38 monoclonal antibody. Data presented from the study showed that at a median follow-up time of 18 months (range, 1.5 to 30.5), single treatment with cilta-cel resulted in profound and long-lasting responses. Ninety-eight percent of patients with MMRR responded to treatment and 80% of patients achieved strict complete response (sCR). The sCR is a measurement used to indicate when a physician is unable to observe signs or symptoms of disease through imaging or other tests after treatment.

“Patients who relapsed, or for whom treatment regimens stopped working after experimenting with the three main drug classes, typically face poor survival. Despite recent innovation, new therapeutic approaches are still needed,” said Maria-Victoria Mateos, Consulting Physician in Hematology, University Hospital of Salamanca, in the press release. “The CARTITUDE-1 data, upon which the EC approval is based, show that a single infusion of cilta-cel resulted in durable responses in a heavily pretreated patient population. These results confirm the potential of cilta-cel to offer patients and physicians a valuable new treatment option. »

“The approval of Janssen’s first cell therapy demonstrates our continued commitment to advancing science and transforming outcomes for people with multiple myeloma,” said Sen Zhuang, Vice President, Clinical Oncology Research, Janssen. Research & Development, in the press release.

J&J has an exclusive worldwide license and collaboration agreement with Legend Biotech USA through its subsidiary, Janssen Biotech, which entered into the agreement in December 2017 to develop and commercialize cilta-cel.


1. U.S. National Library of Medicine, “A study of JNJ-68284528, a chimeric antigen receptor (CAR-T) T-cell therapy directed against B-cell maturation antigen (BCMA) in participants with relapsed or refractory multiple myeloma (CARTITUDE-1),” clinicaltrials.govMay 20, 2022.

Source: Johnson & Johnson