Pivotal TOURMALINE-MM1 Results Demonstrated that the Addition of Oral Ixazomib to Lena­lido­mide and Dexamethasone Significantly Extended Progression-Free Survival, with Limited Additional Toxicity in Patients with Relapsed/Refractory Multiple Myeloma

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that results from the inter­na­tional, ran­dom­ized, double-blind, placebo-controlled TOURMALINE-MM1 Phase 3 clin­i­cal study, eval­u­ating once-weekly oral NINLARO® (ixazomib) capsules plus lena­lido­mide and dexa­meth­a­sone versus placebo plus lena­lido­mide-dexamethasone in patients with re­lapsed and/or refractory multiple myeloma, have been published in the prestigious New England Journal of Medicine (NEJM). NINLARO was recently approved by the U.S. Food and Drug Admin­istra­tion (FDA), based on the pivotal TOURMALINE-MM1 data, in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of …

Good morning, myeloma world.

Things have settled down here at Myeloma Morning Headquarters compared to how they were 36 hours ago. We once again have 21^st century tech­nology doing what it is supposed to be doing. It's wonderful.

Speaking of wonderful, let's talk some more about the multiple myeloma research to be presented at the upcoming 2016 annual meeting of the American Society of Clinical Oncology (ASCO). We discussed the meeting in the previous edition of Myeloma Morning, noting that ASCO has re­leased the titles – but not the abstracts – …

We hope you had a pleasant Wednesday, myeloma world.

Our Wednesday was going full steam ahead until modern tech­nology at Myeloma Morning Headquarters decided to take a vaca­tion. And this had to hap­pen, of course, on a day when we have some particularly in­ter­est­ing devel­op­ments to discuss.

What “developments” might those be, you ask?

Well, those “developments” would be the titles of all pre­sen­ta­tions to be given at the 2016 annual meeting of the American Society of Clinical Oncology (ASCO). The titles were made public on Wednesday.

In this edition of

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.

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 …

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 …