> ## 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.

# J&J Files sBLA for Darzalex Faspro
- URL: https://www.fdaweb.com/j-j-files-sbla-for-darzalex-faspro/
- Published: 2024-09-30T12:00:00.000Z
- Updated: 2026-09-14T14:42:45.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157883

Johnson & Johnson has submitted a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) for a new indication — combination use with bortezomib, lenalidomide and dexamethasone (D-VRd) for treating adults with newly diagnosed multiple myeloma for whom autologous stem cell transplant is deferred or not appropriate.

The filing is based on data from the Phase 3 CEPHEUS study ([NCT03652064](https://c212.net/c/link/?t=0&l=en&o=4265903-1&h=2633851704&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03652064%23study-plan&a=NCT03652064&ref=fdaweb.com)), which showed 60.9% of treated patients achieved minimal residual disease-negativity with D-VRd and the risk of progression or death was reduced by 43%, according to the company. The study also showed that D-VRd significantly reduced the risk of progression or death by 43% vs VRd, and reached an overall complete response rate of 81.2% with D-VRd vs 61.6% with VRd.

Darzalex Faspro [received](https://c212.net/c/link/?t=0&l=en&o=4265903-1&h=4097888564&u=https%3A%2F%2Fwww.janssen.com%2Fus%2Fsites%2Fwww%5Fjanssen%5Fcom%5Fusa%2Ffiles%2Fdarzalex%5Ffaspro%5Fapproval%5Fpress%5Frelease%5Ffinal.pdf&a=received&ref=fdaweb.com) initial approval 5/2020, and is currently approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.