This application seeks to expand the current indication, using Darzalex in combination with bortezomib (a proteasome inhibitor [PI]), melphalan and prednisone, for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.
If approved, this would be the fifth indication for Darzalex in the US and its first in the frontline setting.
As part of the application, Janssen has requested priority review; the FDA will inform Janssen whether priority review has been granted within the next 60 days.
The regulatory submission is based on data from the Phase 3 ALCYONE (MMY3007) study of Darzalex in combination with bortezomib, melphalan and prednisone in frontline multiple myeloma.
Darzalex (daratumumab) injection for intravenous use is the first approved CD38-directed antibody. CD38 is a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.
Darzalex is believed to induce tumor cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity and antibody-dependent cellular phagocytosis, as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.
Janssen, a pharmaceutical company of Johnson and Johnson (NYSE: JNJ), works to find new and better ways to prevent, intercept, treat, and cure disease.
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