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
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 […]readmore
Shots: The approval is based on P-III ALCYONE study results assessing Darzalex + VMP (bortezomib, melphalan and prednisone) vs VMP as monothx. in 706 newly diagnosed patients with multiple myeloma […]readmore
Shots: The BLA submission is based on P-III COLUMBA & P-II PLEIADES studies. P-III COLUMBA study involves assessing Darzalex SC vs Darzalex IV in 522 patients with MM prior treated […]readmore
Shots: The approval is based on P-III MAIA study results assessing Darzalex + Lenalidomide + Dexamethasone (Rd) vs Rd as monothx. in 737 newly diagnosed patients with multiple myeloma ineligible […]readmore
Shots: The sBLA is based on P-III CASSIOPEIA (MMY3006) study results assessing Darzalex + VTd in 1085 patients newly diagnosed with multiple myeloma, eligible for high -dose CT & autologous […]readmore
Shots: The P-III MAIA study results involve assessing of Darzalex + lenalidomide + dexamethasone (Rd) vs Rd in 737 patients with newly diagnosed multiple myeloma ineligible for high-dose CT & […]readmore
Shots: The P-III MMY3021 study involves assessing of daratumumab (1800mg, SC) + lenalidomide vs lenalidomide as monothx. in 214 newly diagnosed multiple myeloma patients who are MRD + after autologous […]readmore
Shots: The P-III COLUMBA (NCT03277105) study involves assessing of Darzalex (SC) + recombinant human hyaluronidase PH20 (2000 U/mL) vs Darzalex (IV) in 522 patients with r/r multiple myeloma The P-III […]readmore
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