Cell-Based IO
Regulatory & Standards

FDA Delays PDUFA Date for BCMA CAR-T Therapy, Cilta-Cel, Until February 2022

Georgi Makin
4 November 2021
Janssen has announced a delay to the planned Prescription Drug User Fee Act (PDUFA) date from the 29th November 2021 to the 28th February 2022.

Cilta-cel (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA) CAR-T therapy currently under investigation for use in the treatment of adults with relapsed and/or refractory multiple myeloma.

In December 2020, Janssen announced that the company had initiated a rolling submission of its Biologics License Application (BLA) to the FDA, later announcing the application had been accepted under Priority Review in May 2021.

Six months later, the PDUFA date has been extended by three months, reportedly to ‘allow sufficient time to review information recently submitted by the company’. This follows an information request from the FDA for an updated analytical method. No additional clinical data have subsequently been requested.

Cilta-cel is described as a ‘BCMA-directed, genetically modified autologous T-cell immunotherapy’. This involves the reprogramming of a patient’s own T-cells with a transgene encoding a chimeric antigen receptor, that will identify and subsequently eliminate cells expressing BCMA, namely in this case, multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells.

Once bound, the CAR promotes T-cell activation, expression and elimination of the target myeloma cells.

In December 2017, Janssen Biotech Inc announced an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. for the development and commercialisation of cilta-cel.

Source: Janssen press release