• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• Approval based on Phase III MAIA study

Copenhagen, Denmark (Press Release); June 27, 2019 – 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 lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of adult 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., under the Real-Time Oncology Review (RTOR) pilot pro­gram. …

• U.S. FDA grants Priority Review for dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed patients with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant
• September 26, 2019 PDUFA date

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) granted a Priority Review for the supple­mental Biologics License Application (sBLA) for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) as treat­ment for patients newly diag­nosed with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen), in March 2019. Priority Review is a …

• Supplemental new drug appli­ca­tion (sNDA) submitted in Japan for dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone as treat­ment for patients newly diag­nosed with multiple myeloma who are not can­di­dates for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III MAIA study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharma­ceu­tical K.K. has submitted a supple­mental new drug appli­ca­tion (sNDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan, for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) as treat­ment for patients newly diag­nosed with multiple myeloma who are not can­di­dates for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT). The MHLW will grant a priority review of the appli­ca­tion, based on the …

First DARZALEX com­bi­na­tion treat­ment regi­men being pursued in the frontline setting for trans­plant eli­gible patients with multiple myeloma

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 bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) for newly diag­nosed patients with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The Phase 3 CASSIOPEIA (MMY3006) clin­i­cal study, which sup­ports the sBLA sub­mission, met its pri­mary end­point – the proportion of patients that achieved stringent Complete Response (sCR) after in­duction and con­sol­i­da­tion …

• sBLA submitted to U.S. FDA for dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed patients with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III CASSIOPEIA 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 (U.S. FDA) for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTD) as treat­ment for newly diag­nosed patients with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). In August 2012, Genmab granted Janssen an exclusive world­wide license to develop, manu­fac­ture and com­mer­cial­ize dara­tu­mu­mab. …

Application sup­ported by the Phase 3 MAIA study for dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of patients newly diag­nosed with multiple myeloma who are in­eligible for au­tol­o­gous stem cell trans­plant

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced the sub­mission of a Type II variation appli­ca­tion to the European Medicines Agency (EMA) for DARZALEX®▼ (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of patients newly diag­nosed with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

“Today’s sub­mission brings us one step closer to our goal of im­prov­ing treat­ment out­comes for people newly diag­nosed with multiple myeloma,” said José Antonio Burón Vidal, VP Medical Affairs, Europe, Middle East and …

• Type II variation appli­ca­tion submitted to the EMA for dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed multiple myeloma patients who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III MAIA study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation appli­ca­tion to the European Medicines Agency (EMA). The appli­ca­tion seeks to broaden the existing mar­ket­ing authori­za­tion for dara­tu­mu­mab (DARZALEX®) to in­clude use in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) as treat­ment for newly diag­nosed multiple myeloma patients who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT). The sub­mission is based on data from the Phase III …