> ## 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.

# Janssen sBLA for Darzalex FasPro for Amyloidosis
- URL: https://www.fdaweb.com/janssen-sbla-for-darzalex-faspro-for-amyloidosis/
- Published: 2020-09-10T12:00:00.000Z
- Updated: 2026-09-14T16:28:21.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147624

Janssen Pharmaceutical Companies has submitted a supplemental BLA for Darzalex *FasPro* (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, for treating patients with light chain amyloidosis, a life-threatening disorder that occurs when plasma cells in bone marrow produce abnormal light chains that form amyloid deposits, which build up in vital organs and eventually cause organ deterioration. The submission is being reviewed under FDA’s Real-Time Oncology Review program, which allows data for certain applications to be reviewed before the applicant formally submits the complete application. It is also being reviewed under [Project Orbis](https://c212.net/c/link/?t=0&l=en&o=2912295-1&h=145018968&u=https%3A%2F%2Fwww.fda.gov%2Fabout-fda%2Foncology-center-excellence%2Fproject-orbis&a=Project+Orbis&ref=fdaweb.com), an FDA Oncology Center of Excellence program that provides a framework for concurrent submission and review of oncology medicine applications among international regulatory agencies, Janssen says.

The supplemental BLA is supported by data from the Phase 3 ANDROMEDA study, which were [presented](https://c212.net/c/link/?t=0&l=en&o=2912295-1&h=984949376&u=https%3A%2F%2Fwww.jnj.com%2Fsubcutaneous-daratumumab-combination-resulted-in-deep-and-rapid-hematologic-responses-and-improved-clinical-outcomes-in-the-treatment-of-patients-with-newly-diagnosed-light-chain-al-amyloidosis&a=presented&ref=fdaweb.com) as a late-breaking abstract at the European Hematology Association Annual Congress in June. “ANDROMEDA evaluated subcutaneous daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone and met its primary endpoint of overall hematologic complete response rate,” the company says.

FDA had originally granted accelerated approval for Darzalex in 2015 to treat patients with multiple myeloma who have received at least three prior treatments.