Toronto, ON (Press Release) – Teva Canada Limited, a sub­sid­i­ary of Teva Pharma­ceu­tical Industries Ltd., announced that Health Canada has approved its appli­ca­tion for the generic version of ^PrBortezomib for Injection for the fol­low­ing indi­ca­tions:

• As part of com­bi­na­tion ther­apy for the treat­ment of patients with pre­vi­ously untreated multiple myeloma who are unsuitable for stem cell trans­plan­ta­tion.
• For the treat­ment of progressive multiple myeloma in patients who have received at least one prior ther­apy and who

 …

Application Designed to Support Conversion of Accelerated to Full FDA Approval

Thousand Oaks, Calif., March 30, 2015 (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has accepted the supple­mental New Drug Application (sNDA) of Kyprolis® (car­filz­o­mib) for Injection for the treat­ment of patients with re­lapsed multiple myeloma who have received at least one prior ther­apy. The sNDA is designed to sup­port the conversion of accelerated approval to full approval and expand the current Kyprolis indi­ca­tion. As part of the acceptance, the FDA granted Kyprolis priority review with a Prescription Drug User Fee Act …

Initial results of a large, head-to-head clinical trial show that re­lapsed myeloma patients treated with high-dose Kyprolis and dex­a­meth­a­sone had twice the pro­gres­sion-free survival of re­lapsed patients treated with Velcade and dex­a­meth­a­sone.

Median pro­gres­sion-free survival in the Phase 3 trial was 18.7 months in trial participants treated with high-dose Kyprolis (car­filz­o­mib) and dex­a­meth­a­sone (Decadron), compared to 9.4 months in patients treated with Velcade (bor­tez­o­mib) and dex­a­meth­a­sone.

The results of the so-called “ENDEAVOR” trial were announced this past Sunday evening in a press release issued by Amgen …

Study Met Primary Endpoint of Progression-Free Survival
Patients Receiving Kyprolis Lived Twice as Long Without Disease Progression

Thousand Oaks, CA and South San Francisco, CA (Press Release) – Amgen (NASDAQ: AMGN) and its sub­sid­i­ary Onyx Pharma­ceu­ticals, Inc., today announced the results from a planned interim analysis showing that the Phase 3 head-to-head clin­i­cal trial ENDEAVOR eval­u­ating Kyprolis® (car­filz­o­mib) for Injection in com­bi­na­tion with low-dose dexa­meth­a­sone versus Velcade® (bor­tez­o­mib) and low-dose dexa­meth­a­sone met the pri­mary end­point of pro­gres­sion-free survival (PFS). Patients with re­lapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clin­i­cally sig­nif­i­cant superiority over Velcade (median PFS 18.7 …

Thousand Oaks, CA and South San Francisco, CA (Press Release) – Amgen (NASDAQ: AMGN) and its sub­sid­i­ary Onyx Pharma­ceu­ticals, Inc., today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) of Kyprolis® (car­filz­o­mib) for Injection for the treat­ment of patients with re­lapsed multiple myeloma who have received at least one prior ther­apy. The MAA has been granted accelerated assess­ment by the EMA.

Kyprolis is a pro­te­a­some inhibitor, one of the classes of drugs used to treat multiple myeloma, an incurable blood cancer affecting ap­prox­i­mate­ly 89,000 people in …

Takeda Oncology yesterday announced posi­tive results from a key trial testing the in­ves­ti­ga­tional drug ixazomib in re­lapsed multiple myeloma patients.

Participants in the large Phase 3 ixazomib trial, known as the TOUR­MA­LINE MM-1 study, received one of two possible treat­ment regi­mens. One group was treated with ixazomib, Revlimid (lena­lido­mide), and dexa­metha­sone (Decadron), while the other group received a placebo (sugar pill), Revlimid, and dexa­metha­sone.

Investigators conducting the trial recently carried out the first planned interim analysis of the study results. Their analysis, Takeda reported yesterday, found …

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 …