J&J Receives EC Conditional Approval for its First Cell Therapy Product for Multiple Myeloma

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

The 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 May 26, 2022 company press release. The therapy has been approved to treat adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody, and who have demonstrated disease progression on the last therapy.

The conditional marketing authorization was supported by a pivotal Phase Ib–II study (CARTITUDE-1), which is ongoing (1). The study includes patients who had received a median of six prior treatment regimens (range, three to 18), and had previously received an IMiD, PI, and an anti-CD38 monoclonal antibody. Data presented from the study showed that, at a median duration of 18 months follow-up (range, 1.5–30.5), a one-time treatment with cilta-cel resulted in deep and durable responses. Ninety-eight percent of patients with RRMM responded to the therapy, and 80% of patients achieved a stringent complete response (sCR). sCR is a measure used to denote when a physician is unable to observe any signs or symptoms of disease through 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,” said Maria-Victoria Mateos, consultant physician in Hematology, University Hospital of Salamanca, in the press release. “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.”

"The approval of Janssen’s first cell therapy is testament to our ongoing commitment to advance science and transform outcomes for those living with multiple myeloma,” said Sen Zhuang, vice-president, Oncology Clinical 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 formed the agreement in December 2017 to develop and commercialize cilta-cel.



1. US National Library of Medicine, “A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1),” clinicaltrials.gov, May 20, 2022.

Source: Johnson & Johnson