Silver Spring, MD (Press Release) – On November 21, 2016, the U.S. Food and Drug Admin­istra­tion ap­proved dara­tu­mumab (DARZALEX, Janssen Biotech, Inc.) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of patients with multiple myeloma who have re­ceived at least one prior ther­apy.

Daratumumab was pre­vi­ously granted accelerated approval in November 2015 as mono­therapy for patients with multiple myeloma who have received at least three prior lines of ther­apy, in­­clud­ing a pro­te­a­some in­hib­i­tor (PI) and an immuno­modu­la­tory agent, or who are double refractory to a PI and …

• DARZALEX sig­nif­i­cantly im­proved pro­gres­sion-free survival (PFS) in com­bi­na­tion with two standard of care regi­mens versus standard of care regi­mens alone
• Approval based on two Phase 3 studies showing con­sis­tent and pronounced clin­i­cal benefit of DARZALEX in com­bi­na­tion with two of the most widely used treat­ment classes for multiple myeloma

Horsham, PA (Press Release) – Janssen Biotech, Inc. announced today the U.S. Food and Drug Admin­is­tra­tion (FDA) has approved DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy.¹ Clinical studies have shown that DARZALEX, in com­bi­na­tion with lena­lido­mide (an immuno­modu­la­tory agent) and dexa­meth­a­sone, reduced the risk of disease pro­gres­sion or death by 63 per­cent, com­pared to lena­lido­mide and dexa­meth­a­sone alone, in patients with …

• New Phase III study combining dara­tu­mu­mab, car­filz­o­mib and dexa­metha­sone in re­lapsed / refractory multiple myeloma – dosing ex­pec­ted in 2017
• First study under Clinical Trial Collaboration and Supply Agreement be­tween Janssen and Amgen
• Agreement covers all poten­tial oppor­tu­ni­ties combining dara­tu­mu­mab and car­filz­o­mib to treat cancer

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that dara­tu­mu­mab (DARZALEX®) will be in­ves­ti­gated in a Phase III clin­i­cal study in com­bi­na­tion with car­filz­o­mib (KYPROLIS®) and dexa­meth­a­sone in patients with re­lapsed/refractory multiple myeloma. The study will be conducted under a master clin­i­cal trial col­lab­o­ration and supply agree­ment be­tween Genmab’s licensing partner for dara­tu­mu­mab, Janssen Biotech, Inc., and Onyx Pharma­ceu­ticals, Inc., a wholly-owned sub­sid­i­ary of Amgen, Inc. The agree­ment covers all poten­tial oppor­tu­ni­ties for combining dara­tu­mu­mab and …

• If authorized, NINLARO will provide a new treat­ment option for European patients with multiple myeloma who have received at least one prior ther­apy
• Opinion based on TOURMALINE-MM1 trial, in which NINLARO plus lena­lido­mide and dexa­meth­a­sone dem­onstrated 6 month im­prove­ment in pro­gres­sion-free survival versus the placebo regi­men

Cambridge, MA, and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the con­di­tional approval of NINLARO^TM (ixazomib) capsules in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy. If the European Com­mis­sion ratifies the CHMP’s opinion and authori­za­tion is granted, NINLARO will be the …

• Application to broaden label for dara­tu­mu­mab for re­lapsed multiple myeloma submitted to EMA by Janssen
• Submission based on data from two Phase III studies, CASTOR and POLLUX
• Genmab to receive USD 10 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 variation to the Marketing Authori­za­tion to the European Medicines Agency (EMA) seeking to broaden the existing mar­ket­ing authori­za­tion for dara­tu­mu­mab (DARZALEX®) to in­clude treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy. The sub­mission of the appli­ca­tion triggers mile­stone pay­ments totaling USD 10 million to Genmab from Janssen. The mile­stone pay­ments were in­cluded in …

Supplemental Biologics License Application (sBLA) seeks second indi­ca­tion for dara­tu­mu­mab in combi­na­tion with standard of care regi­mens for patients with multiple myeloma who have received at least one prior ther­apy

Raritan, NJ (Press Release) – Janssen Biotech, Inc. announced today a supple­mental Biologics License Application (sBLA) for dara­tu­mu­mab (DARZALEX®) has been submitted to the U.S. Food and Drug Admin­is­tra­tion (FDA). The appli­ca­tion seeks to expand the current indi­ca­tion, using dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide (an immuno­modu­la­tory agent) and dexa­meth­a­sone, or bor­tez­o­mib (a pro­te­a­some inhibitor [PI]) and dexa­meth­a­sone, for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy. Dara­tu­mu­mab received Break­through Therapy Desig­na­tion from the FDA for this pending indi­ca­tion on July 25, 2016.

"Daratumumab has been …

• sBLA submitted to U.S. FDA for dara­tu­mu­mab for treat­ment of patients with re­lapsed multiple myeloma
• Submission based on data from two Phase III studies, CASTOR and POLLUX
• Genmab to receive USD 15 million in mile­stone pay­ments from Janssen

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 lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of patients with multiple myeloma who received at least one prior ther­apy. In July 2016, dara­tu­mu­mab was granted a Break­through Therapy Desig­na­tion (BTD) in this patient pop­u­la­tion. …