Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE:4502) today announced that the ran­dom­ized, double-blind, placebo-controlled TOURMALINE-MM1 pivotal Phase 3 trial eval­u­ating the safety and efficacy of ixazomib, the first oral pro­te­a­some inhibitor, conducted in patients with re­lapsed or refractory multiple myeloma (MM) achieved its pri­mary end­point of im­prov­ing pro­gres­sion-free survival at the first pre-specified interim analysis. In the trial, patients treated with inves­ti­ga­tional ixazomib plus lena­lido­mide and dexa­meth­a­sone lived without their disease worsening for a sig­nif­i­cantly longer time compared to patients who received placebo plus lena­lido­mide/dexamethasone.

Efficacy …

US Submission Designed to Support Conversion From Accelerated to Full FDA Approval and Expansion of Current Approved Indication
EMA Grants Kyprolis Accelerated Assessment and Orphan Drug Desig­na­tion

Thousand Oaks, CA and South San Francisco, CA (Press Release) – Amgen (NASDAQ:AMGN) and its sub­sid­i­ary Onyx Pharma­ceu­ticals, Inc., today announced the sub­mission of a supple­mental New Drug Application (sNDA) to the U.S. Food and Drug Admin­istra­tion (FDA) and a Marketing Authorization Ap­pli­cation (MAA) to the European Medicines Agency (EMA) for Kyprolis® (car­filz­o­mib) for Injection to seek approval for the treat­ment of patients with re­lapsed multiple myeloma who have received at least one prior ther­apy. In the U.S., the sNDA is designed to sup­port the conversion of accelerated approval …

Basel, Switzerland (Press Release) - Novartis announced today that the US Food and Drug Admin­istra­tion (FDA) has extended their priority review period by up to three months for the new drug appli­ca­tion (NDA) of LBH589 (panobinostat) in com­bi­na­tion with bor­tez­o­mib* and dexa­meth­a­sone for patients with pre­vi­ously treated multiple myeloma.

 …

• This Phase I trial will test the safety and tolerability of lirilumab (BMS-986015) in combination with elotuzumab (BMS-901608) in patients with multiple myeloma
• This new Phase I initiated by Bristol-Myers Squibb is the first combination trial of lirilumab in a hematological tumor type

Marseille, France (Press Release) - Innate Pharma SA (the "company" -  euronext paris:FR0010331421 - IPH), the innate immunity com­pany devel­op­ing first-in-class thera­peutic anti­bodies for cancer and in­flam­ma­tory dis­eases, to­day an­nounced that a new Phase I com­bi­na­tion trial with lirilumab, a …

• Results show statistically significant and clinically relevant increase in median progression-free survival with LBH589 plus bortezomib and dexamethasone[1]
• LBH589, a first-in-class treatment for patients with relapsed/refractory multiple myeloma if approved, helps extend benefit of standard-of-care therapy[1]
• First Phase III study to demonstrate superiority of a three-drug over two-drug combination in this patient population[1]
• Multiple myeloma, the second most common blood cancer, is incurable; most patients will relapse or become refractory so new treatments are needed[2],[3]

 …

Thousand Oaks, California and South San Francisco, California (Press Release) - Amgen (NASDAQ: AMGN) and its sub­sid­i­ary, Onyx Pharma­ceu­ticals, Inc., today announced that the Phase 3 clin­i­cal trial FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study) did not meet its pri­mary end­point of im­prov­ing over­all survival (OS) (HR=0.975, 95 per­cent CI, 0.760, 1.249). The 315-patient, open-label study eval­u­ated single-agent Kyprolis® (car­filz­o­mib) for Injection compared to an active control regi­men of low-dose dexa­meth­a­sone, or equivalent corticosteroids, plus optional cyclo­phos­pha­mide in patients with re­lapsed and ad­vanced refractory multiple myeloma. Nearly all patients in …

Cambridge, MA (Press Release) – Millennium: The Takeda Oncology Company with its parent com­pany, Takeda Pharma­ceu­tical Company Limited (TSE:4502), today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved VELCADE® (bor­tez­o­mib) for the retreatment of adult patients with multiple myeloma (MM) who had pre­vi­ously responded to VELCADE ther­apy and re­lapsed at least six months fol­low­ing completion of prior VELCADE treat­ment. The labeling update in­cludes dosing guidelines as well as safety and efficacy findings for the use of VELCADE as a single agent or VELCADE in com­bi­na­tion with dexa­meth­a­sone in patients …