• First and only immunostimulatory anti­body approved for mul­ti­ple myeloma
• Approval based on ELOQUENT-2, which estab­lish­ed the com­bi­na­tion of Empliciti with lena­lido­mide and dexa­metha­sone (Rd) de­liv­ered a sig­nif­i­cant pro­gres­sion-free sur­vival ben­e­fit vs. Rd alone, dem­onstrated over two years (HR 0.70 [95% CI: 0.57, 0.85; p = 0.0004])

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the U.S. Food and Drug Admin­istration (FDA) has approved Empliciti (elo­tuzu­mab) for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy with Revlimid® (lena­lido­mide) and dexa­meth­a­sone (ERd) in patients who have re­ceived one to three prior ther­a­pies. The ap­prov­al of this first and only immuno­stimulatory anti­body for mul­ti­ple myeloma is based on data from the ran­dom­ized, open-label, Phase 3, ELOQUENT-2 study, which dem­onstrated that the …

Silver Spring, MD (Press Release) – On No­vem­ber 30, 2015, the U. S. Food and Drug Admin­istra­tion approved elotuzumab (EMPLICITI, Bristol-Myers Squibb Com­pany) in com­bi­na­tion with lena­lido­mide and dexa­metha­sone for the treat­ment of patients with mul­ti­ple myeloma who have re­ceived one to three prior ther­a­pies.

Elotuzumab is a mono­clonal anti­body directed against Signaling Lymphocyte Activation Molecule Family 7 (SLAMF7). SLAMF7 is present on myeloma cells and is also present on natural killer cells.

The ap­prov­al was based on a multi­center, ran­dom­ized, open-label, con­trolled trial eval­u­ating pro­gres­sion-free sur­vival (PFS) and over­all re­sponse …

Silver Spring, MD (Press Release) – Today the U.S. Food and Drug Admin­istra­tion granted ap­prov­al for Empliciti (elo­tuzu­mab) in com­bi­na­tion with two other ther­a­pies to treat people with mul­ti­ple myeloma who have re­ceived one to three prior medi­ca­tions.

Multiple myeloma is a form of blood cancer that oc­curs in in­fec­tion-fighting plasma cells (a type of white blood cell) found in the bone mar­row. These can­cer­ous cells multiply, pro­duce an ab­nor­mal pro­tein and push out other healthy blood cells from the bone mar­row. This dis­ease may re­­sult in a weakened im­mune sys­tem, and …

NINLARO Provides a New Option for Patients Living with Multiple Myeloma Who Have Received at Least One Prior Therapy

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved NINLARO^® (ixazomib) capsules, the first and only oral pro­te­a­some inhibitor, indicated in com­bi­na­tion with lena­lido­mide and dexa­metha­sone for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy. NINLARO is a once-weekly pill. More in­­for­ma­tion is avail­able at www.NINLARO.com.

Takeda submitted a New Drug Application for NINLARO to the FDA in July 2015, and in September NINLARO was granted Priority Review …

Silver Spring, MD (Press Release) – On November 20, 2015, the U.S. Food and Drug Admin­istra­tion approved ixazomib (NINLARO, Millennium Pharma­ceu­ticals, Inc., a wholly owned sub­sid­i­ary of Takeda Pharma­ceu­ti­cal Company Limited) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy. Ixazomib is the first approved oral pro­te­a­some inhibitor.

The approval was based on an im­prove­ment in pro­gres­sion- free survival (PFS) in a multi­center, ran­dom­ized, double-blind, placebo-controlled trial enrolling 722 patients with multiple myeloma who had received 1 to 3 …

Silver Spring, MD (Press Release) – Today the U.S. Food and Drug Admin­istra­tion granted approval for Ninlaro (ixazomib) in com­bi­na­tion with two other ther­a­pies to treat people with multiple myeloma who have received at least one prior ther­apy.

Multiple myeloma is a form of blood cancer that occurs in in­fec­tion-fighting plasma cells (a type of white blood cell) found in the bone marrow. These can­cer­ous cells multiply, produce an ab­nor­mal protein and push out other healthy blood cells from the bone marrow. The disease may result in a weakened immune system and …

First Irreversible Proteasome Inhibitor for Relapsed Multiple Myeloma Approved in the European UnionApproval Based on Data From Pivotal Phase 3 ASPIRE Trial Which Demonstrated Patients Treated With Kyprolis in Combination Lived Nearly Nine Months Longer Without Disease Progression Compared to Common Treatment Course

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced the European Com­mis­sion (EC) granted market­ing authori­za­tion for Kyprolis^® (car­filz­o­mib) in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy. Kyprolis is the first irreversible pro­te­a­some inhibitor approved in the European Union (EU) for use in com­bi­na­tion treat­ment of patients with re­lapsed multiple myeloma.¹

"The approval of Kyprolis in com­bi­na­tion provides physicians and patients across Europe with an im­por­tant new treat­ment option for re­lapsed multiple myeloma, helping to address a real unmet need for this …