• 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 …

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV today announced the sub­mission of a Type II variation appli­ca­tion to the European Medicines Agency (EMA), for the immuno­therapy DARZALEX®▼ (dara­tu­mu­mab). The appli­ca­tion seeks to broaden the existing mar­ket­ing authori­sa­tion to in­clude 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.

“This sub­mission to health author­i­ties takes us one step closer to our goal of redefining com­bi­na­tion ther­apy in multiple myeloma, with the poten­tial to make dara­tu­mu­mab …

• Application to broaden label for dara­tu­mu­mab in front line multiple myeloma sub­mitted to EMA
• Submission based on data from Phase III ALCYONE study
• Genmab to receive USD 3 million in mile­stone pay­ments from Janssen

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). This appli­ca­tion seeks to broaden the existing mar­ket­ing authori­za­tion for dara­tu­mu­mab (DARZALEX®) to in­clude use 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). The sub­mission of the appli­ca­tion triggers mile­stone …

DARZALEX com­bi­na­tion ther­apy offers a new option for patients pre­vi­ously treated with two commonly used treat­ments (lena­lido­mide and a pro­te­a­some inhibitor)

Horsham, PA (Press Release) – Janssen Biotech, Inc. announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the immuno­therapy DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least two prior ther­a­pies in­­clud­ing lena­lido­mide (an immuno­modu­la­tory agent) and a pro­te­a­some inhibitor (PI).¹ Clinical trial results showed an over­all response rate (ORR) of 59.2 per­cent with DARZALEX in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone in these patients.¹

DARZALEX is the first CD38-directed anti­body approved any­where in the world.² It was …

First-in-class CD38-directed mono­clonal anti­body now approved for use in com­bi­na­tion with two standard of care regi­mens

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV (“Janssen”) today announced that the European Com­mis­sion (EC) has granted approval to DARZALEX®▼ (dara­tu­mu­mab) for use in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib (VELCADE®) and dexa­meth­a­sone, for the treat­ment of adult patients with multiple myeloma (MM) who have received at least one prior ther­apy.

The EC’s de­ci­sion was based on data from the Phase 3 POLLUX (MMY3003) study, presented in the plenary session at ASCO 2016 and published in the New England Journal of Medicine, in August 2016¹; and Phase 3 CASTOR (MMY3004) study, presented …