Darzalex (daratumumab) combination regimen significantly improved outcomes for newly diagnosed multiple myeloma patients who are transplant ineligible. Data from the Janssen Research & Development Phase 3 ALCYONE study, showed that Darzalex (daratumumab) in combination with bortezomib, melphalan, and prednisone (VMP) significantly improved clinical outcomes, including reducing the risk of disease progression or death by 50 percent, in patients…
Janssen Seeks To Expand Darzalex For Transplant Ineligible Myeloma Patients
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. Janssen Biotech, Inc. announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Darzalex (daratumumab). The application seeks to expand the…
