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) for use as frontline (initial) ther­apy.¹ The recom­men­da­tion is for the use of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone, for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).¹

“Multiple myeloma be­comes harder to treat each time it returns, so …

• CHMP issued pos­i­tive opinion for DARZALEX for front line multiple myeloma
• Final de­ci­sion from European Com­mis­sion ex­pec­ted in the coming months
• Opinion based on data from Phase III ALCYONE study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) 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® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP) for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell …

• DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients
• Today's FDA approval of DARZALEX® in com­bi­na­tion with bortez­o­mib, mel­phalan and pred­ni­sone marks its fifth indi­ca­tion in multiple myeloma

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson an­nounced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved DARZALEX® (dara­tu­mu­mab) in combi­na­tion with VELCADE® (bor­tez­o­mib)*, a pro­teasome inhibitor (PI); mel­phalan, an alkylat­ing agent; and pred­ni­sone – VMP – for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for autol­o­gous stem cell trans­plant (ASCT). DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients with this disease. Clinical trial results showed DARZALEX® in combi­na­tion with …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA 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
• First approval for DARZALEX in a frontline indi­ca­tion

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of DARZALEX® (dara­tu­mu­mab) in combi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP) for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible 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., in November 2017. The U.S. FDA sub­se­quently granted priority review to the …

• U.S. FDA grants Priority Review to dara­tu­mu­mab in combi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma in­eli­gible for au­tol­o­gous stem cell trans­plant
• May 21, 2018 PDUFA date

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istration (FDA) has granted Priority Review to the supple­mental Biologics License Application (sBLA) for the use of dara­tu­mu­mab (DARZALEX®) 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). The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., in November 2017. Priority Review is an FDA desig­na­tion …

Supplemental Biologics License Application (sBLA) seeks first indi­ca­tion for DARZALEX for the treat­ment of newly diag­nosed patients

Raritan, NJ (Press Release) – Janssen Biotech, Inc. today announced that it has submitted a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for DARZALEX® (dara­tu­mu­mab). This appli­ca­tion seeks to expand the current indi­ca­tion, using DARZALEX in com­bi­na­tion with bor­tez­o­mib (a pro­te­a­some inhibitor [PI]), mel­phalan and pred­ni­sone, for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­planta­tion (ASCT). If approved, this would be the fifth indi­ca­tion for DARZALEX in the U.S. and its first in the frontline setting.

"The addi­tion …

• sBLA submitted to U.S. FDA for dara­tu­mu­mab in combi­na­tion with bortez­omib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma in­eli­gible for au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III ALCYONE study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc., has submitted a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for the use of dara­tu­mu­mab (DARZALEX®) 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). In August 2012, Genmab granted Janssen an exclusive world­wide license to devel­op, manu­facture and com­mer­cial­ize dara­tu­mu­mab.

“We …