Application sup­ported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot pro­gram

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

The sBLA, based upon data from the Phase 3 MAIA (MMY3008) clin­i­cal study, is being reviewed by the FDA under the Real-Time Oncology Review (RTOR) pilot pro­gram, which for …

• First part of regu­la­tory package submitted to the U.S. FDA for label expansion of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for patients with newly diag­nosed multiple myeloma who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant
• The U.S. FDA plan to review the sub­mission under their Real-Time Oncology Review Pilot Program
• Application based on data from Phase III MAIA (MMY3008) study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc. (Janssen), has submitted the first part of a regu­la­tory sub­mission to the U.S. Food and Drug Admin­istra­tion (U.S. FDA) for a label expansion to in­clude the use of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT).  The U.S. FDA plans to …

DARZALEX® com­bi­na­tion ther­apy sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death com­pared to a preferred regi­men alone.^1,2

Toronto, ON (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today that Health Canada has approved DARZA­LEX® (dara­tu­mu­mab), in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP), for the treat­ment of patients newly diag­nosed with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plan­ta­tion.³ DARZA­LEX® is the first mono­clonal anti­body to be approved for newly diag­nosed patients in Canada.

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow un­con­trol­lably in the bone marrow.^4,5 The dis­ease can be very complex to treat as most patients …

• Phase III MAIA study of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone in front line multiple myeloma met the pri­mary end­point (PFS) at a pre-planned interim analysis demonstrating the superiority of DRd over Rd
• Independent Data Moni­tor­ing Committee rec­om­mends releasing the interim analysis results and to follow patients for survival and long-term safety
• Data will be discussed with health author­i­ties to prepare for regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today topline results from the Phase III MAIA study (MMY3008) of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (DRd) versus Rd alone as treat­ment for newly diag­nosed patients who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT). The study met the pri­mary end­point of im­prov­ing pro­gres­sion free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.55 (95% CI 0.43 – 0.72), p …

• Phase III CASSIOPEIA study of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone in front line multiple myeloma met the pri­mary end­point of stringent Complete Response (sCR) after induction and con­sol­i­da­tion ther­apy
• Trial sponsored by the French Intergroupe Francophone du Myelome (IFM) in col­lab­o­ration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON)
• Data will be discussed with health author­i­ties for poten­tial regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today the study met its pri­mary end­point for Part 1 of the Phase III CASSI­OPEIA study (MMY3006) of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTD) versus VTD alone as frontline treat­ment for patients who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). The first part of the study met the pri­mary end­point of number of patients that achieved a sCR, which was reported in 28.9% of patients treated with …

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced that the European Com­mis­sion (EC) has granted mar­ket­ing authori­sa­tion for Darzalex^® (dara­tu­mu­mab) for use as frontline (initial) ther­apy. The approval is for the use of 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 trans­plant (ASCT).

The approval is based on results from the ran­domised, open-label, multicentre Phase 3 ALCYONE (MMY3007) study, published in the New England Journal of Medicine …

• DARZALEX approved in Europe in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone in patients with newly diag­nosed multiple myeloma
• Approval follows pos­i­tive opinion by European Committee for Medicinal Products for Human Use (CHMP) in July
• Genmab to receive mile­stone pay­ment of USD 13 million from Janssen upon first sale of DARZALEX in the newly approved indi­ca­tion

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the European Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for 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 trans­plant (ASCT). The EC approval follows a pos­i­tive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in July 2018. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) …