Shots: The approval is based on P-III APOLLO study evaluating Darzalex Faspro (SC) + pomalidomide & dexamethasone (Pd) vs Pd alone in 304 patients with RRMM who have received at […]readmore
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
Shots: The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment The company evaluated the […]readmore
Shots: The sBLA submission is based on P-III ANDROMEDA study assessing Darzalex Faspro (SC) + bortezomib, cyclophosphamide, and dexamethasone (D-VCd) vs VCd as monothx. in 388 patients with newly diagnosed […]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 P-III ANDROMEDA (AMY3001) study involves assessing of Daratumumab (SC) + cyclophosphamide + bortezomib + dexamethasone (CyBorD) vs CyBorD as monothx. in 388 patients newly diagnosed with AL amyloidosis, […]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
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
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