FDA Approves Expanded Storage Options for Kite CAR T-Cell Products

The Food and Drug Administration approved labeling updates for two of Kite Pharma’s chimeric antigen receptor (CAR) T-cell therapies to provide additional flexibility for product storage at authorized treatment centers.

The approvals — for axicabtagene ciloleucel (Yescarta) and brexucabtagene autoleucel (Tecartus) — allow both therapies to be stored at temperatures of less than or equal to -120 degrees Celsius in mechanical freezers for up to their 12-month shelf life. Under the revised labeling, products may be transferred once from vapor-phase liquid nitrogen storage (less than or equal to -150 degrees Celsius) to storage at less than or equal to -120 degrees Celsius.

In addition, treatment centers may store the products once at -80 degrees Celsius (plus or minus 10 degrees Celsius) for up to 90 days within the labeled expiration period. Products cannot be returned to colder storage after transfer to -80 degrees Celsius. Prior to shipment, both therapies will continue to be stored in vapor-phase liquid nitrogen.

Both products are autologous CD19-directed CAR T-cell therapies indicated for certain hematologic malignancies.