Application to Expand Daratumumab Indication Submitted to FDA

Janssen Biotech, Inc. has submitted a supplemental Biologics License Application (sBLA) for daratumumab to the U.S. Food and Drug Administration (FDA), seeking to expand the current indication to patients with multiple myeloma who have received at least 1 prior therapy.¹

Rather than monotherapy, daratumumab would be used in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for this expanded indication.

“Daratumumab has been shown to provide clinically meaningful benefit as a backbone therapy in combination with two of the most widely used treatment regimens for multiple myeloma,” said Peter F. Lebowitz, MD, PhD, Global Oncology Head, Janssen Research & Development, LLC. “Today’s submission marks an important step forward in realizing the full potential of daratumumab earlier in the treatment pathway, and we look forward to working with the FDA during its review of our application.”

A request for Priority Review of this sBLA has also been submitted. If granted, the review of the sBLA is expected to be completed within 6 months.

The application is based on findings from 2 clinical studies, CASTOR and POLLUX. The CASTOR trial demonstrated that daratumumab with bortezomib and dexamethasone reduced the risk of progression or death by 61% compared with bortezomib and dexamethasone alone; POLLUX showed daratumumab in combination with lenalidomide and dexamethasone reduced that risk by 63% vs lenalidomide and dexamethasone alone. Both studies included patients who had received at least 1 prior therapy.

Daratumumab is currently approved by the FDA as a single agent for the treatment of patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.

Reference

1. Janssen submits application to U.S. FDA to expand indication for daratumumab (Darzalex). PR Newswire website. http://www.prnewswire.com/news-releases/janssen-submits-application-to-us-fda-to-expand-indication-for-daratumumab-darzalex-300315019.html?tc=eml_cleartime. Updated August 17, 2016. Accessed August 18, 2016.