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Darzalex ®▼ (daratumumab) approved for reimbursement in Ireland in Combination with Bortezomib, Thalidomide and Dexamethasone (VTd) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

  • Approval is based on data from the Phase 3 CASSIOPEIA trial, which demonstrated that the addition of daratumumab resulted in deeper response rates and improved progression-free survival (PFS) compared to VTd alone1
  • Reimbursement follows the European Commission’s approval in 2020 when Daratumumab-VTd became the first regimen approved in over six years for newly diagnosed patients who are eligible for a stem cell transplant2
  • Daratumumab has been used to treat more than 100,000 patients worldwide3
  • This is the sixth approval for daratumumab and the third in the frontline setting4

Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced today Darzalex®(daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) has been granted reimbursement in Ireland for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The announcement follows EC approval of daratumumab based on results from Part one of the Phase 3 CASSIOPEIA (MMY3006) study, published in The Lancet5 in June 2019 and presented at the 2019 American Society of Clinical Oncology (ASCO) Meeting.

Professor Philip Murphy, Consultant Haematologist, Beaumont Hospital said: “For Irish patients newly diagnosed with multiple myeloma, the importance of early intervention with effective first-line treatments to maximise response cannot be emphasised enough. Improvements in the standard of care to provide patients with valuable extra time are vital. Data from the CASSIOPEIA study demonstrates that the addition of daratumumab in combination with VTd can lead to deep remissions and prolong PFS.”

Dr Thorsten Giesecke, General Manager, Commercial Business, Janssen Sciences Ireland UC, said: “Janssen is committed to providing access for patients to daratumumab in earlier disease stages of multiple myeloma, a type of blood cancer that can have a devastating impact on the lives of those affected. Every year in Ireland about 350 people are diagnosed with this condition, and today’s reimbursement provides those who are newly diagnosed and transplant eligible, with a long-awaited additional frontline therapy.”6

The Phase 3 CASSIOPEIA trial is a two-part study. Results from this first part of the trial showed that after consolidation, the stringent complete response (sCR) rate was significantly higher in the daratumumab-VTd arm (29 percent) compared to VTd alone (20 percent) (Odds Ratio [OR] = 1.60; 95 percent confidence interval [CI], 1.21-2.12; P<0.0010).2 At a median follow-up of 18.8 months, PFS was significantly improved in the daratumumab-VTd group compared to VTd alone (Hazard Ratio [HR] = 0.47; 95 percent CI, 0.33-0.67; P<0.0001), and the median PFS was not reached in either arm.2 The addition of daratumumab to VTd resulted in an 18-month PFS rate of 93 percent compared to 85 percent for VTd alone.2

The most common (≥10%) Grade 3/4 treatment-emergent adverse events (TEAEs) for daratumumab-VTd and VTd, respectively, were neutropenia (28 percent vs. 15 percent), lymphopenia (17 percent vs. 10 percent), stomatitis (13 percent vs. 16 percent) and thrombocytopenia (11 percent vs. 7 percent).2 In the daratumumab-VTd combination arm, infusion-related reactions occurred in 35 percent of patients.2

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