Good morning, myeloma world.

As we were finalizing today's edition of Myeloma Morning, we were suddenly reminded of how inter­na­tional the field of multiple myeloma research truly is.

The first research study we review below is by a team of German researchers. We also discuss two studies by Korean researchers, and a topic sparked by a report written by Chinese researchers. At the end of today's report, the list of new myeloma research articles also in­cludes publications by investigators in India, Israel, Italy, and the United States.

As we …

Good morning, myeloma world.

We have a slightly different edition of Myeloma Morning cooked up for you today than is usually the case. Although we have one new myeloma research study that we will review – see the discussion further below about Cometriq – we will spend most of today's edition looking in more detail at an issue discussed in this Monday's edition of Myeloma Morning.

In that article, we discussed a recent study by physicians at the Mayo Clinic's Arizona campus. The Mayo Clinic study concerns a con­di­tion known …

Good morning, myeloma world.

We hope your week is getting off to a good start. We've got a couple of new research studies to discuss in today's edition of Myeloma Morning, as well as several highlights from the Beacon's discussion forum.

On the research front, we'll start today by mentioning an article by physicians at the Mayo Clinic's Arizona campus. They report on a com­pli­ca­tion, known as thrombotic microangiopathy (TMA), that occurred in two multiple myeloma patients they had treated with Kyprolis (car­filz­o­mib) (abstract).

TMA is a con­di­tion marked …

• 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 …

• 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 …