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FDA priority review granted for J&J, Legend Biotech’s myeloma CAR T therapy

CAR T therapy demonstrated an overall response rate of 97% in relapsed/refractory multiple myeloma patients after 12.4 months

Johnson & Johnson (J&J) and Legend Biotech’s CAR T therapy ciltacabtagene autoleucel has been granted a priority review by the US Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma.

The investigational B-cell maturation antigen (BCMA) CAR T therapy, also known as cilta-cel, is backed by results from the phase 1b/2 CARTITUDE-1 study.

This study is evaluating the safety and efficacy of cilta-cel in adults with relapsed/refractory multiple myeloma who have received at least three prior lines of therapy or who are double refractory to a proteasome inhibitor and immunomodulatory drug and an anti-CD38 antibody.

In this study, the CAR T therapy demonstrated an overall response rate of 97% in relapsed/refractory multiple myeloma patients after a median follow-up of 12.4 months.

In addition, 67% of patients achieved a stringent complete response after a median 12.4 months of follow-up time.

On the safety front, cytokine release syndrome (CRS) was seen in 95% of patients in this study, with 3% of these cases being grade 3 and 1% being grade 4 or grade 5.

J&J also reported that there were 14 deaths in the trial, with six of these caused by adverse events related to cilta-cel treatment.

“Cilta-cel has shown great promise in the treatment of patients with heavily pretreated multiple myeloma according to study findings reported to date. Today’s priority review designation marks another significant milestone for this cell therapy,” said Ying Huang, chief executive officer and chief financial officer of Legend Biotech.

J&J initially licensed cilta-cel from Legend in December 2017 to develop and commercialise the CAR T therapy for an upfront payment of $350m.

In December 2019, the European Commission also granted cilta-cel a Priority Medicines (PRIME) designation.

J&J has also submitted a biologics licence application seeking approval for cilta-cel from the FDA, and a marketing authorisation application has also been accepted by the European Medicines Agency.

Article by
Lucy Parsons

27th May 2021

From: Regulatory

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