Shots: The P-III MAIA study assessing Darzalex + lenalidomide & dexamethasone (DRd) vs Rd in 737 newly diagnosed patients aged 45-90yrs. with MM ineligible for high-dose CT & ASCT MAIA […]readmore
Tags : DARZALEX
Shots: The approval is based on P-lll CASSIOPEIA (MMY3006) Study involve the assessing of Darzalex (daratumumab) + bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with multiple myeloma […]readmore
Shots: The US FDA has approved Janssen’s Darzalex + Amgen’s Kyprolis (carfilzomib) and dexamethasone (DKd) in two dosing regimen (70 mg/m2 , qw and 56 mg/m2 , q2w) for the […]readmore
Shots: The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients The […]readmore
Shots: The sBLA is based on P-III CANDOR study assessing Darzalex + carfilzomib + dexamethasone (DKd) vs Kd as monothx. in 466 patients with r/r MM prior treated with 1L+ […]readmore
Shots: The approval is based on P-III CASSIOPEIA studyassessingDarzalex + bortezomib, thalidomide and dexamethasone (VTd) vs VTd in 1085 newly diagnosed patients with previously untreated, symptomatic MM, who were eligible […]readmore
Regulatory
Janssen’s Darzalex (daratumumab) Combination Regimen Receives CHMP’s Positive Opinion for
Shots: The CHMP positive opinion is based on P-III CASSIOPEIA (MMY3006) study assessing the combination of Darzalex + bortezomib, thalidomide and dexamethasone vs bortezomib, thalidomide and dexamethasone alone in 1,085 […]readmore
Shots: The P-III CANDOR study involves assessing of KYPROLIS (56 mg/m2) + dexamethasone + DARZALEX vs KYPROLIS and dexamethasone monothx in 466 relapsed or refractory multiple myeloma patients who have […]readmore
Regulatory
Janssen’s Darzalex (daratumumab) Combination Regimen Receives EC’s Approval for Transplant
Shots: The EC’s approval is based on P-III MAIA study assessing Darzalex + lenalidomide and dexamethasone (DRd) vs Rd in 737 newly diagnosed patients aged 45-90yrs. with multiple myeloma ineligible […]readmore
Shots: The approval is based on P-III MAIA study assessing Darzalex + lenalidomide + dexamethasone (Rd) vs Rd as monothx. in 737 patients with newly diagnosed multiple myeloma who are […]readmore