Results of a recent British study in­di­cate that the rel­a­tive­ importance of factors affecting sur­vival in multiple myeloma patients changes with patient age.

In particular, the re­searchers found that the older a patient is at diag­nosis, the more their sur­vival is affected by their general health and by how ad­vanced their multiple myeloma is at diag­nosis.

In contrast, the impact of high-risk chromosomal ab­nor­mal­i­ties on sur­vival de­creases with patient age.

The study findings are based on an analysis of data for almost 4,000 newly diag­nosed multiple myeloma patients who par­tic­i­pated in the …

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 …

Silver Spring, MD (Approval & Safety Notification) – On Sep­tem­ber 26, 2019, the Food and Drug Admin­istra­tion approved dara­tu­mu­mab (DARZALEX, Janssen) for adult patients with multiple myeloma in com­bi­na­tion with bor­tez­o­mib, thalido­mide, and dexa­meth­a­sone in newly diag­nosed patients who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

Efficacy was in­ves­ti­gated in CASSIOPEIA (NCT02541383), an open-label, ran­dom­ized, active-controlled phase 3 study com­par­ing induction and con­sol­i­da­tion treat­ment with dara­tu­mu­mab 16 mg/kg in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (DVTd) to treat­ment with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) in patients with newly diag­nosed multiple myeloma eli­gible for …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA in com­bi­na­tion with bor­tez­o­mib, thalido­mide (an immuno­modu­la­tory agent) and dexa­meth­a­sone as treat­ment for patients newly diag­nosed with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant
• Approval based on Phase III CASSIOPEIA study

Copenhagen, Denmark (Company Announcement) – 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 bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) as treat­ment for patients newly diag­nosed with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The supple­mental Biologics License Application (sBLA) for this indi­ca­tion was sub­mitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen) in March 2019. The U.S. FDA sub­se­quently granted priority review to the sBLA, …

• DARZALEX® approved in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma in­eli­gible for au­tol­o­gous stem cell trans­plant in Japan
• Genmab to receive USD 7 million mile­stone pay­ment
• Approval based on data from Phase III ALCYONE study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the use of DARZALEX (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). DARZALEX is being devel­oped under an August 2012 agree­ment in which Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive world­wide license to develop, manu­fac­ture and …