Janssen-Cilag International NV, a Johnson & Johnson company, has 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.
Lutsenko_Oleksandr Shutterstock
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).
“It is increasingly evident that to continue optimising outcomes in multiple myeloma, we must intervene early with the most effective therapies first,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Johnson & Johnson Innovative Medicine. “Today’s positive recommendation, based on the CEPHEUS study, brings us closer to offering daratumumab-VRd as a treatment option for patients with NDMM, regardless of transplant eligibility. Together, with results from the PERSEUS study, this demonstrates the potential of daratumumab-based regimens as a foundational frontline therapy for all patient types.”
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). 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.
“For almost a decade, daratumumab has transformed the standard of care in multiple myeloma, and we have remained steadfast in our commitment to continue improving outcomes for all patients with this complex disease," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “As our first registrational study in multiple myeloma with a primary endpoint of MRD-negativity, CEPHEUS underscores our dedication to innovate with purpose, as we unleash the full potential of our portfolio and build on our goal of delivering a cure.”
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. 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.