Janssen Submits New Application to EMA for Darzalex Combo

Janssen Pharmaceuticals recently submitted a Type 2 variation application to the European Medicines Agency (EMA) seeking to broaden the existing marketing authorization for Darzalex (daratumumab). The request includes Darzalex’s combined use with other therapies to advance treatment options for adult patients with multiple myeloma (MM) who are unfit candidates for autologous stem cell transplant.

The announcement was made by Genmab, a biotechnology company that granted Janssen an exclusive license to develop, manufacture, and commercialize Darzalex in August 2012.

“We are very pleased about this submission, which marks the first application for the use of daratumumab for patients with newly diagnosed multiple myeloma. We look forward to working with both Janssen and the EMA so that daratumumab can potentially become available for a broader group of multiple myeloma patients,” Jan van de Winkel, PhD, chief executive officer of Genmab, said in a press release.

Data from the Phase 3 ALCYONE clinical trial (NCT02195479), which evaluated Darzalex in combination with Velcade (bortezomib), Alkeran (melphalan), and prednisone (also known as Deltasone) in newly diagnosed MM patients, were seen to support Janssen’s application.

Darzalex is a human antibody that binds to the CD38 molecule, highly expressed at the surface of MM cells. The antibody triggers a patient’s immune system to attack cancer cells, leading to their death.

In the ALCYONE study, the Darzalex combo was shown to be better at preventing disease progression than the Velcade, melphalan, and prednisone (VMP) combo.

The study was designed to include over 700 newly-diagnosed MM patients not suitable to receive autologous stem cell transplant. Patients were randomized to receive VMP — with or without Darzalex — for nine cycles, after which they continued receiving Darzalex as maintenance therapy for 28-day cycles until disease progression.

The trial’s final data collection date for primary outcome measure is scheduled for November 2017 and should be announced soon.

Darzalex is the first monoclonal antibody to receive approval from the U.S. Food and Drug Administration (FDA) for the treatment of MM. After its publication, final data from the Phase 3 ALCYONE trial will be used as the basis for a potential regulatory submission to FDA.