Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the US Food and Drug Admin­istra­tion, FDA, has granted priority re­view for Oncopeptides' New Drug Appli­ca­tion seek­ing ap­prov­al of mel­flu­fen (INN mel­phalan flufenamide), in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of adult patients with mul­ti­ple myeloma whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory agent and one anti-CD-38 mono­clonal anti­body, (i.e., triple-class re­frac­tory mul­ti­ple myeloma patients). The FDA has set a PDUFA-date (Prescription Drug User Fee Act), which is the target date for their re­view …

• BLENREP is the first anti-BCMA (B-cell maturation an­ti­gen) ther­apy ap­prov­ed in the Euro­pean Union
• Marketing autho­ri­sa­tion follows the recent US ap­prov­al of BLEN­REP

London, United Kingdom (Press Release) – GlaxoSmithKline plc to­day an­nounced the Euro­pean Com­mis­sion has granted con­di­tional mar­ket­ing autho­ri­sa­tion for BLEN­REP (belantamab mafo­dotin) as mono­therapy for the treat­ment of mul­ti­ple myeloma in adult patients who have re­ceived at least four prior ther­a­pies and whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory agent, and an anti-CD38 mono­clonal anti­body, and who have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. BLEN­REP is a first-in-class humanised anti-BCMA (B-cell maturation an­ti­gen) treat­ment for these patients whose …

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 …

• BLENREP is a first-in-class anti-BCMA (B-cell maturation an­ti­gen) ther­apy for patients whose dis­ease has progressed de­spite prior treat­ment with an immuno­modu­la­tory agent, pro­te­a­some in­hib­i­tor and anti-CD38 anti­body
• BLENREP is the fifth major med­i­cine ap­prov­al for GSK in 2020

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) an­nounced the US Food and Drug Admin­istra­tion (FDA) has approved BLEN­REP (belantamab mafo­dotin-blmf) as a mono­therapy treat­ment for adult patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least four prior ther­a­pies in­clud­ing an anti-CD38 mono­clonal anti­body, a pro­te­a­some in­hib­i­tor and an immuno­modu­la­tory agent. This in­di­ca­tion is approved under ac­cel­er­ated ap­prov­al based on re­sponse rate. Continued ap­prov­al for this in­di­ca­tion may be con­tin­gent upon veri­fi­ca­tion and description of clin­i­cal ben­e­fit in …

Lund, Sweden (Press Release) – Active Biotech (NASDAQ STOCKHOLM: ACTI) to­day an­nounces that the first patient has been dosed in the phase 1b/2a clin­i­cal study of tas­quini­mod for treat­ment of re­lapsed or re­frac­tory mul­ti­ple myeloma. The study, which is planned to recruit up to 54 patients, will estab­lish a max­i­mum tol­er­ated dose of tas­quini­mod as single agent and then in­ves­ti­gate tas­quini­mod in com­bi­na­tion with a stan­dard mul­ti­ple myeloma oral regi­men of ix­az­o­mib, lena­lido­mide, and dexa­meth­a­sone (IRd). For both single agent tas­quini­mod and the com­bi­na­tion of tas­quini­mod and IRd, exploratory ex­pan­sion cohorts will be …

• 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 …