Darzalex (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
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 a Type II variation for Darzalex (daratumumab) subcutaneous (SC) formulation.
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 a Type II variation for Darzalex (daratumumab) subcutaneous (SC) formulation. The recommendation is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd), for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). SC formulation was previously approved by the European Commission in June 2020.
The CHMP recommendation for daratumumab is supported by data from the Phase III PERSEUS (NCT03710603) study, evaluating D-VRd induction and consolidation therapy, and daratumumab with lenalidomide (D-R) maintenance therapy, compared to VRd induction and consolidation, and R maintenance, in transplant eligible patients with newly diagnosed multiple myeloma. Data from the study were recently presented at the 2024 American Society of Clinical Oncology (ASCO) 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 transplant-eligible or ineligible for ASCT.3 The positive CHMP opinion follows the recent U.S. Food and Drug Administration (FDA) approval of daratumumab SC in combination with D-VRd for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for ASCT.
About daratumumab and daratumumab SC; Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.
See- "Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma" Authors: Pieter Sonneveld, M.D., Ph.D., Meletios A. Dimopoulos, M.D., +36, for the PERSEUS Trial Investigators*.Published December 12, 2023. N Engl J Med 2024;390:301-313, DOI: 10.1056/NEJMoa2312054 .VOL. 390 NO. 4.
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