News

Janssen Seeks to Expand Darzalex Use for Multiple Myeloma Patients

Janssen Biotech has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand Darzalex (daratumumab) to include patients with multiple myeloma. The application seeks approval for Darzalex use in combination with Revlimid (lenalidomid) and Decadron (dexametasone), or Velcade (bortezomib) and Decadron, in…

German Agency Questions Benefit of Empliciti Reported in Multiple Myeloma Study

Empliciti (elotuzumab), a monoclonal antibody, is approved in both the U.S. and Europe as a treatment, in combination with Revlimid (lenalidomide) and Decatron (dexamethasone), for multiple myeloma patients who have received at least one prior treatment. But the German Institute for Quality and Efficiency in Health and Care (IQWiG) announced  that an early benefit assessment was unable to…