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# Janssen sBLA for Combination Darzalex Use in Myeloma
- URL: https://www.fdaweb.com/janssen-sbla-for-combination-darzalex-use-in-myeloma/
- Published: 2019-09-26T12:00:00.000Z
- Updated: 2026-09-15T01:52:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145103

FDA has approved a Janssen Biotech supplemental BLA for use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for treating patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant. Approval was based on data from part one of the Phase 3 CASSIOPEIA study of 1,085 newly diagnosed patients with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant. The primary endpoint of this part of the study is progression free survival.

Daratumumab is a human IgG1k monoclonal antibody that binds to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells, the company says. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death), it says.