Posted by Michael Wonder on 21 Nov 2017
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
21 November 2017 - Supplemental biologics license application seeks first indication for Darzalex for the treatment of newly diagnosed patients.
Janssen today announced that it has submitted a supplemental biologics license application to the U.S. FDA for Darzalex (daratumumab). This application seeks to expand the current indication, using Darzalex in combination with bortezomib (a proteasome inhibitor), melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. If approved, this would be the fifth indication for Darzalex in the U.S. and its first in the frontline setting.
As part of the application, Janssen has requested priority review, which the FDA grants to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition. The FDA will inform Janssen whether priority peview has been granted within the next 60 days.
The regulatory submission is based on data from the Phase 3 ALCYONE (MMY3007) study of Darzalex in combination with bortezomib, melphalan and prednisone in frontline multiple myeloma.
