Darzalex-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma

The CHMP recommendation for daratumumab is supported by data from the Phase 3 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.

“Since its initial European approval in 2016, daratumumab has become a foundational therapy for the treatment of multiple myeloma, and we have remained dedicated to harnessing its full potential for all patients at every stage of the disease,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “Today’s positive recommendation reflects our unwavering commitment to advancing novel therapies and transformative combination regimens, like D-VRd, towards the ultimate goal of eliminating this complex disease.”

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.

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.