Healthcare company Janssen Biotech Inc revealed on Tuesday that it has filed a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) for DARZALEX (daratumumab) for the treatment of patients with newly diagnosed multiple myeloma, an incurable blood cancer.
Via the US FDA application, the company 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).
Following approval, this would be the fifth indication for DARZALEX in the US and its first in the frontline setting, added the company.
DARZALEX (daratumumab) injection for intravenous use is the first CD38-directed antibody approved anywhere in the world. 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, according to the company.
This regulatory submission is based on data from the company's Phase 3 ALCYONE (MMY3007) study of DARZALEX in combination with bortezomib, melphalan and prednisone in frontline multiple myeloma. These data were also used as the basis for a regulatory submission to the European Medicines Agency (EMA).
Under the sBLA, the company has requested Priority Review, which the US FDA grants to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition. The US FDA's Priority Review is expected within the next 60 days.
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