GSK plc has unveiled positive outcomes from the DREAMM-7 head-to-head phase III trial, evaluating Blenrep (belantamab mafodotin) as a treatment for relapsed or refractory multiple myeloma. This pivotal trial demonstrated a statistically significant progression-free survival (PFS) benefit for Blenrep combined with bortezomib and dexamethasone (BorDex) against the daratumumab plus BorDex regimen. Trial Details and Efficacy […]
Legend Biotech has announced the submission of a Type II variation application to the European Medicines Agency (EMA) for CARVYKTI (ciltacabtagene autoleucel or cilta-cel), based on data obtained from the CARTITUDE-4 study (NCT04181827). This study focuses on the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have undergone one to three prior […]
DARZALEX FASPRO FDA approval for AL amyloidosis : Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has secured approval from the US Food and Drug Administration (FDA) for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) for the treatment of light chain (AL) amyloidosis, which has been newly diagnosed in […]
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) seeking the expanded approval for DARZALEX (daratumumab) in subcutaneous (SC) formulation to include the treatment of patients having light chain (AL) amyloidosis. Considered as a rare and potentially fatal disease, AL amyloidosis is due […]
DKd regiment FDA approval for multiple myeloma : Janssen Pharmaceutical Companies of Johnson & Johnson and Amgen have been granted an expanded approval from the US Food and Drug Administration (FDA) for the DKd regimen comprising the former’s DARZALEX (daratumumab) and the latter’s Kyprolis (carfilzomib) plus dexamethasone for the treatment of multiple myeloma. The approval […]
CANDOR clinical trial results : Amgen said that a phase 3 study assessing Kyprolis (carfilzomib) in combination with dexamethasone and Johnson & Johnson’s Darzalex (daratumumab) (KdD) compared to Kyprolis and dexamethasone alone (Kd), called CANDOR, met its primary endpoint of progression-free survival (PFS) in multiple myeloma patients. The Amgen clinical trial featured 466 relapsed or […]
Janssen Pharmaceutical Companies of Johnson & Johnson encountered a significant setback with their esketamine nasal spray in a phase 3 trial aimed at treating patients with treatment-resistant depression. The trial’s results revealed that esketamine did not meet its primary endpoint, sparking concern among industry experts and stakeholders. The late-stage study assessed the efficacy of two […]
The Janssen Pharmaceutical Companies of Johnson & Johnson have achieved a significant milestone with the European Commission’s approval of Darzalex (daratumumab) for use as an initial therapy in adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). This approval allows for the combination of daratumumab with bortezomib, […]
