Janssen Biotech has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand Darzalex (daratumumab) to include patients with multiple myeloma. The application seeks approval for Darzalex use in combination with Revlimid (lenalidomid) and Decadron (dexametasone), or Velcade (bortezomib) and Decadron, in patients who received at least one prior therapy.
“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,” Dr. Peter F. Lebowitz, MD, PhD, global oncology dead of Janssen Research & Development, said in a press release.
“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,” he said.
CD38 is a surface protein that is highly expressed across multiple myeloma cells, irrespective of disease stage. Darzalex is a monoclonal antibody that targets the CD38-positive cells, inducing their death. It received FDA approval in November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, such as Velcade, and an immunomodulatory agent, such as Revlimid.
Now, Janssen is seeking FDA approval for Darzalex in combination with either Revlimid and Decadron, or Velcade and Decadron, in patients who received at least one previous therapy. The submission is based on two Phase 3 studies, each assessing one of the combinations.
The CASTOR study (NCT02497378) evaluated Darzalex in combination with Revlimid and Decadron versus Revlimid and Decadron alone, showing that the risk of disease progression or death was reduced by 61 percent in the Darzalex group.
The POLLUX study (NCT01615029) assessed the safety and efficacy of Velcade and Decadron with or without Darzalex. The study revealed that Darzalex reduced the risk of disease progression or death by 63 percent.
The submission also included data from the Phase 1 study of Darzalex in combination with Pomalyst (pomalidomide) and Decadron in multiple myeloma patients who had received at least two prior lines of therapy.
This data will also be submitted to the European Medicines Agency (EMA) to seek a similar approval for Darzalex in Europe.
In July, the FDA had granted Darzalex breakthrough therapy designation for this application, a status that is meant to expedite the drug’s development and review. Now, Janssen has also submitted a request for priority review of this sBLA. The FDA will inform Janssen whether the priority review has been granted within the next 60 days, and if the answer is positive, the review should be complete within six months.