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# FDA Priority Review for Janssen Myeloma BLA
- URL: https://www.fdaweb.com/fda-priority-review-for-janssen-myeloma-bla/
- Published: 2021-05-27T12:00:00.000Z
- Updated: 2026-09-14T17:00:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149423

FDA has accepted for priority review a BLA submitted by Janssen for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen-directed chimeric antigen receptor T cell therapy being developed with Legend Biotech to treat relapsed/refractory multiple myeloma. Legend [says](https://www.legendbiotech.com/pdf/LEGN%5FPR%5F05262021.pdf?ref=fdaweb.com) the agency set 11/29 as the PDUFA action date.

The cilta-cel BLA was based on results from the pivotal Phase 1b/2 CARTITUDE-1 study that evaluated the drug’s efficacy and safety in treating patients with relapsed and/or refractory multiple myeloma, Legend says.