• CHMP issued pos­i­tive opinion for DARZALEX® in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant
• Final de­ci­sion from European Com­mis­sion ex­pec­ted in the coming months
• Opinion based on data from Phase III CASSIOPEIA study

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) announced today that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a pos­i­tive opinion rec­om­mending broadening the existing mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in the European Union. The recom­men­da­tion is for the use of DARZALEX in in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). …

• Harpoon grants AbbVie option to license world­wide rights to HPN217 (BCMA), a TriTAC for the treat­ment of multiple myeloma planned for IND filing this year
• Expanded TriTAC discovery col­lab­o­ration in­cludes up to six addi­tional targets selected by AbbVie
• Two agree­ments provide for a total of $50 million in up­front and up to $50 million in a contingent mile­stone pay­ment for first patient treated with HPN217 in a clin­i­cal trial

South San Francisco, CA and North Chicago, IL (Press Release) – Harpoon Thera­peutics, Inc. (NASDAQ: HARP), a clin­i­cal-stage immuno­therapy com­pany devel­op­ing a novel class of T cell engagers, and AbbVie Inc. (NYSE: ABBV), a global bio­pharma­ceu­tical com­pany, today announced an ex­clu­sive world­wide option and license trans­action for HPN217, Harpoon’s B cell maturation an­ti­gen (BCMA)-targeting Tri-specific T cell Activating Construct (TriTAC®), and an ex­pan­sion of their existing discovery col­lab­o­ration for up to six addi­tional targets. These agree­ments build upon the …

• Combination regi­men reduces the risk of dis­ease pro­gres­sion or death by 44 per­cent in newly diag­nosed patients who are trans­plant in­eli­gible¹
• Since launch, dara­tu­mu­mab has been used to treat more than 100,000 patients world­wide²

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) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (DRd) for the treat­ment of newly diag­nosed multiple myeloma patients who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The approval was based on results from the Phase 3 MAIA (MMY3008) study, published in The New England Journal of Medicine³ earlier this year and presented at the American Society of Hematology …

• DARZALEX® approved in Europe in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone as treat­ment for adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• Approval follows pos­i­tive opinion by European Com­mit­tee for Medicinal Products for Human Use (CHMP) in Octo­ber
• Approval based on data from Phase III MAIA study

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) announced today that the European Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) as treat­ment for adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The EC approval follows a pos­i­tive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in Octo­ber 2019. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an …

This DARZALEX® com­bi­na­tion regi­men reduced the risk of dis­ease pro­gres­sion or death by 44% in newly diag­nosed patients who are trans­plant in­eli­gible

Toronto, ON (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced that Health Canada recently approved under Priority Review DARZALEX® (dara­tu­mu­mab), in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd), for newly diag­nosed patients with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The approval is based on results from the Phase 3 MAIA clin­i­cal study published in the New England Journal of Medicine, which showed the DARZALEX®-Rd com­bi­na­tion reduced the risk of dis­ease pro­gres­sion or death by 44 per cent com­pared to treat­ment with Rd alone.¹

Multiple …

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has rec­om­mended broadening the existing mar­ket­ing authori­sa­tion for Darzalex® (dara­tu­mu­mab) to in­clude the use of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (DRd) for patients with newly diag­nosed multiple myeloma (NDMM) who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

“As multiple myeloma can be­come more complex with each relapse, it is im­por­tant that patients receive the latest treat­ment options with the …

• CHMP issued a pos­i­tive opinion for DARZALEX® in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed adult patients with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• Final de­ci­sion from European Com­mis­sion ex­pec­ted in the coming months
• Opinion based on data from Phase III MAIA study

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a pos­i­tive opinion rec­om­mending broadening the existing mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in the European Union. The recom­men­da­tion is for the use of DARZALEX in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) as treat­ment for newly diag­nosed adult patients with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The Type …