Toronto, Canada (Press Release) – Celgene Inc. announced today that Health Canada has expanded the indi­ca­tion for REVLIMID® (lena­lido­mide capsules), in multiple myeloma. REVLIMID® in com­bi­na­tion with dexa­meth­a­sone, is indicated for the treat­ment of multiple myeloma patients who are not eli­gible for stem cell trans­plant.¹ Nearly 60 per cent of newly diag­nosed people living with multiple myeloma are not eli­gible for a stem cell trans­plant,² so the expanded indi­ca­tion provides a new option for this patient pop­u­la­tion, where few existed before.

"The expanded indi­ca­tion of REVLIMID® provides patients with a treat­ment much earlier …

• 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 …

Lund, Sweden (Press Release) – BioInvent Inter­na­tional (STO:BINV) announces that it has decided to terminate its current clin­i­cal Phase II study with BI-505 in multiple myeloma. The de­ci­sion follows BioInvent’s review and discussion with the US Food & Drug Admin­istra­tion (FDA), who put BI-505 on full clin­i­cal hold in November 2016.

The terminated trial, which was per­formed in col­lab­o­ration with Penn Medicine, targeted a specific pop­u­la­tion of multiple myeloma patients undergoing au­tol­o­gous stem cell trans­plan­ta­tion with high-dose mel­phalan.

About BioInvent

BioInvent Inter­na­tional AB (OMXS: BINV) is focused on devel­op­ing a first-in-class and …

Approval Based on TOURMALINE-MM1 Study Results, Which Demonstrated Statistically Significant Six-Month Improvement in Progression-Free Survival

Cambridge, MA, and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the European Com­mis­sion has granted con­di­tional market­ing authori­za­tion for NINLARO^TM (ixazomib) capsules, indicated in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for adult patients with multiple myeloma who have received at least one prior ther­apy. The de­ci­sion to approve NINLARO as the first and only oral pro­te­a­some inhibitor to treat multiple myeloma follows a positive opinion by the European Medicines Agency (EMA) Committee for Medicinal Products (CHMP) for Human Use in September 2016.

“For myeloma patients living …

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 …