Announcement comes as recent clin­i­cal results reveal ixazomib sig­nif­i­cantly extends pro­gres­sion-free survival for patients with re­lapsed / refractory multiple myeloma

Oakville, ON (Press Release) – The New Drug Submission (NDS) for Takeda’s ixazomib has been accepted for priority review by Health Canada. Ixazomib is the first inves­ti­ga­tional oral pro­te­a­some inhibitor for the treat­ment of patients with re­lapsed and/or refractory multiple myeloma. If approved, ixazomib will be the first oral pro­te­a­some inhibitor avail­able in Canada, helping meet the urgent needs of patients living with multiple myeloma, a dev­as­tat­ing, relapsing and incurable rare cancer. With …

What a year 2015 was for the myelomatologist!

The U.S. Food and Drug Admin­istra­tion (FDA) ap­prov­al of three new myeloma drugs, all within the span of a few weeks to­wards the end of the year, had already gen­er­ated great ex­cite­ment in the com­munity.

Then, sev­er­al poten­tial prac­tice-changing pre­sen­ta­tions at the 2015 American Society of He­ma­tol­ogy (ASH) annual meeting put the proverbial icing on the cake to round out a landmark year for myeloma thera­peutics.

This edition of the myeloma quiz highlights some of the key takeaways from the ASH 2015 meeting.

• Pivotal Head-To-Head ENDEAVOR Study Shows Kyprolis and Dexamethasone Doubled Progression-Free Survival Versus Velcade® (Bortezomib) and Dexamethasone
• Kyprolis Label Expansion Represents Critical Advancement for Patients With Relapsed or Refractory Multiple Myeloma, Offering New Option For Backbone Therapy
• Approval Expands Kyprolis Indication and Converts Monotherapy Indication to Full Approval

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the supple­mental New Drug Application (sNDA) of Kyprolis^® (car­filz­o­mib) for Injection in com­bi­na­tion with dexa­meth­a­sone or with lena­lido­mide plus dexa­meth­a­sone for the treat­ment of patients with re­lapsed or refractory multiple myeloma who have received one to three lines of ther­apy. The FDA also approved Kyprolis as a single agent for the treat­ment of patients with re­lapsed or refractory multiple …

Additional Presentation: Phase 2 Results From an Investigational study of Ixazomib plus Cyclophosphamide and Low-Dose Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma

Orlando, FL (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE:4502) today announced results from the TOURMALINE-MM1 trial presented at the 57^th Annual Meeting and Exposition of the American Society of Hematology (ASH), showing that treat­ment with NINLARO^® (ixazomib) capsules is effective in extending pro­gres­sion free survival (PFS) with a man­age­able tolerability profile in patients with re­lapsed and/or refractory multiple myeloma. The TOURMALINE-MM1 trial is an inter­na­tional, ran­dom­ized, double-blind, placebo-controlled Phase 3 clin­i­cal trial designed to eval­u­ate once-weekly oral ixazomib plus lena­lido­mide and dexa­meth­a­sone compared to placebo plus lena­lido­mide and dexa­meth­a­sone.

NINLARO …

• Kyprolis Plus Dexamethasone Doubled Progression-Free Survival to More Than 18 Months Versus Velcade Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
• First Head-to-Head Study Comparing two Proteasome Inhibitors

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) today announced that The Lancet Oncology published results from the pivotal Phase 3 head-to-head ENDEAVOR study com­par­ing Kyprolis^® (car­filz­o­mib) plus dex­a­meth­a­sone to Velcade^® (bor­tez­o­mib) plus dex­a­meth­a­sone in patients with re­lapsed multiple myeloma. The data showed that patients treated with Kyprolis plus dex­a­meth­a­sone achieved pro­gres­sion-free survival (PFS) of 18.7 months compared to 9.4 months in those receiving bor­tez­o­mib plus dex­a­meth­a­sone (HR=0.53; 95 per­cent CI: 0.44,0.65 p<0.0001), a current standard of care in re­lapsed multiple myeloma. …

Data Confirm Efficacy and Safety of Kyprolis Combination Across Range of Patient Populations

Thousand Oaks, CA (Press Release) - Amgen (NASDAQ: AMGN) today announced the presentation of new key data eval­u­ating Kyprolis^® (car­filz­o­mib) -based regi­mens in patients with re­lapsed multiple myeloma. The data showed Kyprolis in com­bi­na­tion with dex­a­meth­a­sone sig­nif­i­cantly extended disease pro­gres­sion com­pared to bor­tez­o­mib plus dex­a­meth­a­sone across a range of dif­fi­cult-to-treat pop­u­la­tions, specifically those with high risk and pre­vi­ously treated disease. The analyses were presented during the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH) in Orlando, Fla.

Data analyzed in three presentations across patient subgroups from the Phase …

Application Based on Pivotal Head-to-Head ENDEAVOR Study Showing Kyprolis Plus Dexametha­sone Doubled Progression-Free Survival Compared to Velcade^® (Bortezomib) Plus Dexamethasone

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced the sub­mission to the European Medicines Agency (EMA) of a Variation to the Marketing Authorization Application (MAA) to expand the indi­ca­tion for Kyprolis^® (car­filz­o­mib) in com­bi­na­tion with dexa­metha­sone for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy.

The appli­ca­tion is based on results from the Phase 3 head-to-head ENDEAVOR study in which patients with multiple myeloma treated with Kyprolis plus dexa­metha­sone achieved superior pro­gres­sion-free survival (PFS) compared to those receiving Velcade® (bor­tez­o­mib) plus …