> ## 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 Pharma sBLA for Darzalex in Multiple Myeloma
- URL: https://www.fdaweb.com/janssen-pharma-sbla-for-darzalex-in-multiple-myeloma/
- Published: 2019-03-26T12:00:00.000Z
- Updated: 2026-09-15T01:15:56.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5143697

Janssen Pharmaceutical has submitted a supplemental BLA seeking approval of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant. The submission is based on data from the [Phase 3 CASSIOPEIA (MMY3006)](https://c212.net/c/link/?t=0&l=en&o=2413514-1&h=3421032129&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02541383&a=Phase+3+CASSIOPEIA+%28MMY3006%29&ref=fdaweb.com) clinical study, which Janssen says met its primary endpoint — the proportion of patients that achieved a stringent complete response after induction and consolidation therapy.

Daratumumab is the first CD38-directed antibody approved to treat multiple myeloma. CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease, according to the company. Darzalex binds to CD38 and inhibits tumor cell growth causing myeloma cell death, it says. The drug is being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant hematologic diseases in which CD38 is expressed, such as smoldering myeloma.