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
November 22, 2017
November 22, 2017
RARITAN, New Jersey, Nov. 22 -- Johnson and Johnson issued the following news release:
Janssen Biotech, Inc. today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for DARZALEX(R) (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 . . .
Janssen Biotech, Inc. today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for DARZALEX(R) (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 . . .