Tags : daratumumab

Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the

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 approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%), with PK & safety profile […]Read More

Genmab Reports Results of Daratumumab Based Combination Therapy in P-III

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, conducted by Janssen The P-III ANDROMEDA study resulted in meeting its 1EPs of the percentage of patients with hematologic complete response (53.3% vs 18.1%), the […]Read More

Janssen Reports Submission of sBLA to the US FDA for

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+ therapies at 120 sites globally The results of P-III CANDOR study support the benefits of triple regimen for patients with MM with 1EPs as PFS […]Read More

Janssen’s Darzalex (daratumumab) Combination Regimen Receives EC’s Approval for Transplant

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 for high-dose CT and stem cell transplant The P-III CASSIOPEIA study results: higher sCR (29% vs 20%); @18.8mos. improvement in PFS (93% vs 85%), published […]Read More

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 newly diagnosed patients with previously untreated symptomatic MM, eligible for ASCT If approved, the combination regimen will be the first Darzalex based regimen that would […]Read More

Janssen’s Darzalex (daratumumab) Combination Therapy Receives FDA’s Approval for Frontline

Shots: The approval is based on P-III CASSIOPEIA (MMY3006) study involve assessing of Darzalex + bortezomib, thalidomide and dexamethasone (VTd) vs VTd in 1,085 newly diagnosed patients with previously untreated symptomatic MM who are eligible for high dose CT and stem cell transplant The P-III CASSIOPEIA study is sponsored by IFM in collaboration with HOVON […]Read More