Janssen has announced that the European Commission (EC) has granted marketing authorisation for a new Darzalex (daratumumab) combo, for newly diagnosed, transplant eligible patients with multiple myeloma (MM).
On the news, the combination, which consists of the biologic combined with bortezomib, thalidomide and dexamethasone (VTd) is now the first regimen approved in over six years for newly diagnosed patients who are eligible for a stem cell transplant. It also means that the patient population now has their first opportunity to be treated with a monoclonal antibody.
The company says that the approval was based on results from part one of the Phase III CASSIOPEIA (MMY3006) study, which showed that after consolidation, the stringent complete response (sCR) rate was 9% higher in the Darzalex-VTd arm than the VTd alone arm.
Further, at a median follow-up of 18.8 months, PFS was significantly improved in the Darzalex-VTd group, with the addition of the drug resulting in an 18-month PFS rate of 93%, compared to 85% for VTd alone.
The effectiveness of first line treatment is “critical to maximise time until relapse,” explained Philippe Moreau, principal investigator and Head of the Haematology Department at the University Hospital of Nantes.
He continued, “The CASSIOPEIA study answered that question definitively, demonstrating that the addition of Darzalex in combination with VTd can lead to very deep remissions and also prolong PFS. I’m pleased to see the European Commission have recognised this as well.”
MM is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells. In Europe, more than 48,200 people were diagnosed with MM in 2018, with more than 30,800 deaths related to the disease.