> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Carvykti Improves Survival in Phase 3 Trial: J&J
- URL: https://www.fdaweb.com/carvykti-improves-survival-in-phase-3-trial-j-j/
- Published: 2024-07-08T12:00:00.000Z
- Updated: 2026-09-14T14:34:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157303

Johnson & Johnson says its Carvykti (ciltacabtagene autoleucel) achieved a statistically significant and clinically meaningful improvement in overall survival in multiple myeloma patients in the Phase 3 CARTITUDE-4 study. A company [statement](https://www.jnj.com/media-center/press-releases/carvykti-ciltacabtagene-autoleucel-achieved-statistically-significant-and-clinically-meaningful-improvement?ref=fdaweb.com) says the trial evaluated Carvykti compared to standard therapies to treat patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy.

The statement says FDA approved Carvykti in 2/2022 to treat adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy. In April, it was approved to treat adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy and who are refractory to lenalidomide, following an FDA Oncologic Drugs Advisory Committee 11-0 vote in favor of the new indication.

Carvykti is described as a BCMA-directed, genetically modified, autologous T-cell one-time infusion immunotherapy that involves reprogramming a patient’s T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR-positive T-cells to eliminate cells that express BCMA.