DARZALEX® com­bi­na­tion ther­apy sig­nif­i­cantly im­proved pro­gres­sion-free survival (PFS) com­pared to standard of care regi­mens alone

Toronto, ON (Press Release) – Janssen Inc. announced today that Health Canada 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 Due to the high unmet medical need for multiple myeloma patients, DARZALEX® was granted a Priority Review by Health Canada for this sub­mission.

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow un­con­trol­lably in the bone marrow.^2,3 The dis­ease can be very complex to treat as …

Janssen’s first-in-class CD38-directed mono­clonal anti­body now rec­om­mended for approval earlier in the treat­ment path­way in com­bi­na­tion with two standard of care regi­mens

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced today 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).¹ If approved by the European Com­mis­sion, dara­tu­mu­mab can be used in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone; or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of adult patients with multiple myeloma (MM) who have received at …

Planegg / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today announced that it has added a second patent with US Patent Number 9,200,061 to its lawsuit against Janssen Biotech, and Genmab, A/S. This patent claims methods of treating hema­to­logic cancer asso­ci­ated with the undesired presence of CD38-positive cells by admin­istering anti­bodies that bind to a specific region of the target molecule, CD38. In a hearing that took place on Feb­ru­ary 6, 2017 the District Court granted MorphoSys's request to add the 9,200,061 patent to the …

• Phase Ib/II studies of dara­tu­mu­mab in com­bi­na­tion with Bristol-Myers Squibb’s (BMS) immune checkpoint inhibitor nivolumab in solid tumors and multiple myeloma to start in 2017
• Studies conducted under a clin­i­cal trial col­lab­o­ration agree­ment be­tween Janssen and BMS

Copenhagen, Denmark – Genmab A/S (Nasdaq Copenhagen: GEN) announced today dara­tu­mu­mab will be in­ves­ti­gated in Phase Ib/II clin­i­cal studies in com­bi­na­tion with nivolumab (a PD-1 check­point inhibitor) in several solid tumor types and in multiple myeloma. The studies will be conducted under a clin­i­cal trial col­lab­ora­tion agree­ment be­tween Genmab’s licensing partner for dara­tu­mu­mab, Janssen Biotech, Inc., and Bristol-Myers Squibb (BMS). The studies will be sponsored by BMS.

The solid tumor studies will eval­u­ate the safety, tolerability and clin­i­cal benefit of dara­tu­mu­mab in com­bi­na­tion with nivolumab …

Phase 1b/Phase 2 studies planned in multiple myeloma and solid tumors

Horsham, PA (Press Release) – Janssen Biotech, Inc. today announced that the com­pany has entered a clin­i­cal trial col­lab­o­ration with Bristol-Myers Squibb Company (BMS) to eval­u­ate the com­bi­na­tion of the first CD38-directed cytolytic anti­body dara­tu­mu­mab (DARZALEX®) and checkpoint inhibitor nivolumab (OPDIVO®) in Phase 1b /Phase 2 clin­i­cal studies in multiple myeloma and several solid tumor types. Nivolumab is devel­oped and com­mer­cial­ized by BMS. Janssen licensed dara­tu­mu­mab from Genmab A/S and is responsible for all global devel­op­ment, mar­ket­ing and manu­fac­tur­ing.

The multiple myeloma study will eval­u­ate the safety and tolerability of dara­tu­mu­mab in com­bi­na­tion with nivolumab …

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 …