Janssen Submits Application to U.S. FDA to Expand Indication for DARZALEX? (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma who are Transplant Ineligible

發(fā)布時(shí)間： 2018-01-08 閱讀：837次

分享

Janssen Biotech, Inc. announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S on Nov. 21, 2017. Food and Drug Administration (FDA) for DARZALEX? (daratumumab). 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 (ASCT). If approved, this would be the fifth indication for DARZALEX in the U.S. and its first in the frontline setting.

DARZALEX? (daratumumab) injection for intravenous use is the first CD38-directed antibody approved anywhere in the world.5 CD38 is a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.6 DARZALEX is believed to induce tumor cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.5 A subset of myeloid derived suppressor cells (MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by DARZALEX.5 DARZALEX 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 7,8,9,10,11,12,13,14Additional studies are ongoing or planned to assess its potential for a solid tumor indication and in other malignant and pre-malignant diseases in which CD38 is expressed, such as smoldering myeloma.15,16,17DARZALEX was the first CD38-directed antibody to receive regulatory approval to treat relapsed or refractory multiple myeloma.2