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# FDA Extends PDUFA Date for Janssen BLA
- URL: https://www.fdaweb.com/fda-extends-pdufa-date-for-janssen-bla/
- Published: 2021-11-02T12:00:00.000Z
- Updated: 2026-09-14T17:21:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150491

FDA has extended to 2/28/22 the PDUFA action date for Legend Biotech and Janssen’s BLA for ciltacabtagene autoleucel (cilta-cel). The companies [say](https://www.marketwatch.com/press-release/janssen-announces-extension-of-us-fda-bla-pdufa-date-for-bcma-car-t-ciltacabtagene-autoleucel-2021-11-01?tesla=y&ref=fdaweb.com) cilta-cel is a B-cell maturation antigen CAR-T therapy that is being investigated for treating adults with relapsed and/or refractory multiple myeloma.

FDA reportedly extended the action date to give sufficient time to review information recently submitted by the company on an updated analytical method following an agency request.

Legend and Janssen say no additional clinical data have been requested and it continues to work with FDA on the ongoing BLA review.