• 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). …

• 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 …

As you may remember from my pre­vi­ous column, I started treat­ment with Darzalex, Revlimid, and dexa­meth­a­sone in early Octo­ber.

By now, I have re­ceived six weekly Darzalex (dara­tu­mu­mab) in­fusions, and quite a bit has hap­pened as I adjust to being on a new regi­men.

After the first in­fusion, I had a mild cough that turned into quite a deep, hacking cough. I could hardly sleep for a week. It didn’t appear to be a "productive" cough, so I took Benadryl (di­phen­hy­dra­mine) and cough med­i­cines and sat upright a lot at …

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 …

Ein Team niederländischer Forscher hat Ergebnisse einer kleinen Studie veröffentlicht, in der die Auswirkungen der Darzalex-Behandlung auf den Immunglobulinspiegel bei Patienten mit multiplem Myelom untersucht wurden.

In ihrer Studie konzentrieren sich die Forscher insbesondere darauf, wie die Werte der unbeteiligten Immunglobuline eines Patienten durch die Behand­lung mit Darzalex beeinflusst werden.

Unbeteiligte Immunglobuline bei Myelompatienten sind Immunglobuline, die einen anderen Subtyp haben als das monoklonale Immunglobulin, das von den Myelomzellen des Patienten hergestellt wird.

Zum Beispiel hat ein Patient mit IgG multiplem Myelom Myelom-Plasmazellen, die monoklonales Immunglobulin G (IgG) produzieren. Für diesen Myelompatienten …

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 …