J&J’s DARZALEX (daratumumab) subcutaneous-based regimen receives positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility
Janssen-Cilag International NV, a Johnson & Johnson company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) formulation in the frontline setting.
The recommendation is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).
The CHMP recommendation is supported by data from the Phase 3 CEPHEUS (NCT03652064) study, evaluating the efficacy and safety of daratumumab-VRd compared to VRd for patients with NDMM who are transplant ineligible or for whom autologous stem-cell transplant (ASCT) was not planned as initial therapy (transplant ineligible or deferred).5,6 Data from the study were previously presented at the 2024 International Myeloma Society (IMS) Annual Meeting and the 2024 American Society of Hematology (ASH) Annual Meeting.
Daratumumab is currently approved in eight indications for multiple myeloma, four of which are in the frontline setting, including as part of treatment regimens for newly diagnosed patients who are eligible or ineligible for ASCT.8 On 23 October 2024, an indication extension for daratumumab-VRd was approved for newly diagnosed patients with multiple myeloma who are eligible for ASCT, following the results from the Phase 3 PERSEUS study that evaluated this daratumumab SC-based quadruplet regimen for induction and consolidation therapy.2,9
Johnson & Johnson also submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration seeking approval of a new indication for daratumumab SC in combination with VRd for the treatment of adult patients with NDMM for whom ASCT is deferred or who are ineligible for ASCT, on 30 September 2024.
Fonte: Johnson & Johnson