Applications sup­ported by pos­i­tive re­sults from the Phase 3 APOLLO study, which dem­onstrated longer pro­gres­sion-free sur­vival in patients re­ceiv­ing the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab¹

RARITAN, N.J., Nov. 12, 2020 /PRNewswire/ -- The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the sub­mission of regu­la­tory appli­ca­tions to the U.S. Food and Drug Admin­istra­tion (FDA) and Euro­pean Medicines Agency (EMA) seek­ing ap­prov­al of the dara­tu­mu­mab sub­cu­tane­ous (SC) for­mu­la­tion, known as DAR­ZA­LEX FASPRO™ (dara­tu­mu­mab and hyal­uron­i­dase-fihj) in the U.S. and as DAR­ZA­LEX® SC in the Euro­pean Union (EU). The appli­ca­tions seek ap­prov­al of the com­bi­na­tion of DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (D-Pd) for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple …

• Second part of the Phase 3 CASSI­O­PEIA study of dara­tu­mu­mab as main­te­nance treat­ment for patients with newly diag­nosed mul­ti­ple myeloma eli­gible for au­tol­o­gous stem cell trans­plant met the pri­mary end­point of pro­gres­sion-free sur­vival at a pre-planned interim analysis
• Independent Data Mon­i­tor­ing Com­mit­tee rec­om­mends unblinding the study re­sults
• Based on the data, Janssen plans to discuss the po­ten­tial for a regu­la­tory sub­mission with health author­i­ties

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day pos­i­tive top­line re­sults from the sec­ond part of the Phase 3 CASSI­O­PEIA (MMY3006) study of dara­tu­mu­mab mono­therapy as main­te­nance treat­ment versus observation (no treat­ment) for patients with newly diag­nosed mul­ti­ple myeloma eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The sec­ond part of the study, which is being con­ducted by the French Intergroupe Francophone du Myelome (IFM) in col­lab­o­ration with the Dutch-Belgian Cooperative Trial Group for He­ma­tol­ogy On­col­ogy (HOVON) and …

Approval broadens DAR­ZA­LEX label to in­clude fifth treat­ment op­tion in the re­lapsed / re­frac­tory setting and rep­re­sents the eighth ap­prov­ed in­di­ca­tion for DAR­ZA­LEX

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the U.S. Food and Drug Admin­istra­tion (FDA) ap­prov­al of DAR­ZA­LEX® (dara­tu­mu­mab) in com­bi­na­tion with Kyprolis® (car­filz­o­mib) and dexa­meth­a­sone (DKd) for the treat­ment of adult patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who have re­ceived one to three pre­vi­ous lines of ther­apy. DAR­ZA­LEX® has been ap­prov­ed in com­bi­na­tion with two car­filz­o­mib dosing regi­mens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on pos­i­tive re­­sults from the Phase 3 CANDOR and Phase 1b EQUULEUS stud­ies, rep­re­senting the first-ever ap­prov­al of an …

• DARZALEX® (dara­tu­mu­mab) ap­prov­ed by U.S. FDA in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone for the treat­ment of adult patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who have re­ceived one to three pre­vi­ous lines of ther­apy
• Approval based on the Phase 3 CANDOR study
• Approval marks eighth U.S. FDA ap­prov­al for DAR­ZA­LEX

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has ap­prov­ed the use of DAR­ZA­LEX® (dara­tu­mu­mab) in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone (DKd) for the treat­ment of adult patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who have re­ceived one to three pre­vi­ous lines of ther­apy. A supple­mental Biologics License Appli­ca­tion (sBLA) for this in­di­ca­tion was sub­mitted by Genmab’s licensing part­ner, Janssen Bio­tech, Inc. (Janssen), in Feb­ru­ary 2020. In August 2012, Genmab granted …

DARZALEX® SC reduces admin­istra­tion time from hours to min­utes and dem­onstrates con­sis­tent ef­fi­cacy with a re­duc­tion in admin­istra­tion-related reac­tions com­pared to in­tra­venous DAR­ZA­LEX® (dara­tu­mu­mab)

Toronto, ON (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day that Health Canada has approved DAR­ZA­LEX® SC (dara­tu­mu­mab), a new sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab.¹ DAR­ZA­LEX® SC is approved in four regi­mens across five in­di­ca­tions in patients with mul­ti­ple myeloma, most notably newly diag­nosed, trans­plant-ineligible patients as well as re­lapsed or re­frac­tory patients. As a fixed-dose for­mu­la­tion, DAR­ZA­LEX® SC can be admin­istered over approx­i­mately three to five min­utes, sig­nif­i­cantly less time than in­tra­venous (IV) DAR­ZA­LEX®, which is admin­istered over hours.² DAR­ZA­LEX® SC is the only sub­cu­tane­ous CD38-directed anti­body approved …

• Phase 3 APOLLO ran­dom­ized study eval­u­ating sub­cu­tane­ous dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone versus poma­lido­mide and dexa­meth­a­sone alone in re­lapsed or re­frac­tory mul­ti­ple myeloma met the pri­mary end­point of im­prov­ing pro­gres­sion-free sur­vival
• Janssen in­tends to discuss the data with health author­i­ties for po­ten­tial regu­la­tory sub­missions

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the Euro­pean Myeloma Network (EMN) in col­lab­o­ration with Janssen Re­search & De­vel­op­ment, LLC (Janssen) re­ported pos­i­tive re­­sults from the Phase 3 APOLLO (MMY3013) study of the sub­cu­tane­ous (SC) for­mu­la­tion of dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (Pd) versus Pd alone as treat­ment for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have pre­vi­ously been treated with lena­lido­mide (an immuno­modu­la­tory drug) and a pro­te­a­some in­hib­i­tor (PI). The study met the pri­mary …

• New sub­cu­tane­ous, fixed-dose for­mu­la­tion of dara­tu­mu­mab reduces treat­ment time from hours to min­utes, with com­parable ef­fi­cacy and fewer in­fusion-related reac­tions^1,2
• Daratumumab is now the only approved sub­cu­tane­ous CD38-directed anti­body for the treat­ment of these mul­ti­ple myeloma in­di­ca­tions in Europe

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day that the Euro­pean Com­mis­sion (EC) has granted mar­ket­ing authori­sa­tion for DAR­ZA­LEX®▼ (dara­tu­mu­mab) sub­cu­tane­ous (SC) for­mu­la­tion for the treat­ment of adult patients with mul­ti­ple myeloma (MM). Dara­tu­mu­mab SC is admin­istered as a fixed dose, which sig­nif­i­cantly reduces treat­ment time, from hours to approx­i­mately three to five min­utes, when com­pared to dara­tu­mu­mab in­tra­venous (IV) for­mu­la­tion.¹ In addi­tion, only the first dose of dara­tu­mu­mab SC needs to be admin­istered in an en­viron­ment where resuscitation …