Janssen Submits Application to FDA to Expand Indication for DARZALEX

Janssen Biotech has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for DARZALEX (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 multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT). If approved, this would be the fifth indication for DARZALEX in the U.S. and its first in the frontline setting.

"The addition of DARZALEX to this treatment regimen provides a substantial, clinically meaningful impact on prolonging remission for newly diagnosed patients with multiple myeloma," said Mark Wildgust, Vice President, Global Medical Affairs, Janssen Oncology. "Today's submission builds upon the consistent clinical benefit of DARZALEX in combination with standard of care regimens and is an exciting step forward for patients and physicians."

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 Review 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.

DARZALEX was first approved by the FDA in November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. It received additional approvals in November 2016 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. In June 2017, DARZALEX was approved in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI.