The United States Food and Drug Admin­istra­tion (FDA) has approved ixazomib for the treat­ment of multiple myeloma.

The drug will be marketed under the brand name Ninlaro. It should be avail­able in U.S. pharmacies by the middle of next month, according to a spokesperson from Takeda Oncology, the com­pany that developed Ninlaro and will be mar­ket­ing it globally.

Ninlaro is the second new multiple myeloma ther­apy approved by the FDA this week. The agency on Monday announced the approval of Darzalex (dara­tu­mu­mab) for the treat­ment of myeloma …

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 …

The European Commission has approved Kyprolis (car­filz­o­mib) for the treat­ment of multiple myeloma.

The approval means that, for the first time, myeloma patients in Europe will be able to be treated with Kyprolis without having to enroll in a clinical trial.

Although Kyprolis was approved in the United States more than three years ago, the Phase 2 clinical trial that was the basis for that approval was not sufficient for a European approval. Additional data from a larger Phase 3 clinical trial had to be collected for …

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 …

-- Plenary Presentation at the 15th Inter­na­tional Myeloma Workshop --

Toronto, ON and San Diego, CA (Press Release) – Triphase Accelerator Corpo­ra­tion, a private drug de­vel­op­ment com­pany dedicated to ad­vanc­ing novel com­­pounds through Phase 2 proof-of-concept, today an­nounced pre­lim­i­nary results of a Phase 1 dose-escalation study of marizomib in com­bi­na­tion with poma­lido­mide (POM) and low dose dex­a­meth­a­sone (Lo-DEX) in patients with re­lapsed and refractory multiple myeloma. The marizomib/POM/Lo-DEX com­bi­na­tion was able to de­crease myeloma proteins by at least 50 per­cent to achieve an over­all response rate of 62 per­cent in …