NINLARO™ is the first and only oral pro­te­a­some inhibitor approved to provide a new treat­ment option for adult patients living with mul­ti­ple myeloma in Canada who have received at least one prior ther­apy

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE:4502) today announced Takeda Canada has received approval from Health Canada for NINLARO™ (ixazomib) capsules in com­bi­na­tion with lena­lido­mide and dexa­meth­asone for the treat­ment of adult patients with mul­ti­ple myeloma who have received at least one prior ther­apy. In Canada, it is esti­mated that approx­i­mately 7,500 people live with mul­ti­ple myeloma. The approval was primarily based on the results of the final analysis of the pivotal Phase 3 trial, TOURMALINE-MM1, which dem­onstrated that NINLARO in com­bi­na­tion with lena­lido­mide and dexa­metha­sone …

• FDA action underscores poten­tial clin­i­cal benefit of dara­tu­mu­mab as a back­bone ther­apy in com­bi­na­tion with either a pro­te­a­some inhibitor (PI) or an immuno­modu­latory agent for patients who have received at least one prior ther­apy
• Marks the second Break­through Therapy Desig­na­tion for dara­tu­mu­mab

Raritan, NJ (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has granted a Break­through Therapy Desig­na­tion to the immuno­therapy dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with lena­lido­mide (an immuno­modu­la­tory agent) and dexa­metha­sone, or bor­tez­o­mib (a pro­te­a­some inhibitor [PI]) and dexa­metha­sone, for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy, Janssen Research & Development, LLC announced today. This marks the second time dara­tu­mu­mab has received a Break­through Therapy Desig­na­tion, which is in­tended to expedite the devel­op­ment and …

• Daratumumab receives Break­through Therapy Desig­na­tion in com­bi­na­tion with standard of care regi­mens for multiple myeloma patients who have received at least one prior line of ther­apy
• Potential for accelerated review
• Marks second Break­through Therapy Desig­na­tion for dara­tu­mu­mab

Copenhagen, Denmark (Press Release) — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Break­through Therapy Desig­na­tion for DARZALEX^® (dara­tu­mu­mab) injection in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy. Break­through Therapy Desig­nation is a pro­gram in­tended to expedite the devel­op­ment and review of drugs to treat serious or life-threatening diseases in cases where pre­lim­i­nary clin­i­cal …

A new ther­apy providing an im­por­tant option for multiple myeloma patients who have received three or more prior lines of ther­apy

Toronto, Canada (Press Release) – Janssen Inc. announced today Health Canada has issued a Notice of Compliance with Conditions (NOC/c) approving DARZALEX™ (dara­tu­mu­mab) for the treat­ment of patients with multiple myeloma who have received at least three prior lines of ther­apy in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or who are refractory to both a PI and an IMiD. Health Canada approved this prod­uct on the con­di­tion that Janssen Inc. carries out con­firmatory trials to verify the clin­i­cal benefit of DARZALEX™.¹

Multiple myeloma is an incurable blood cancer that …

A team of European researchers has pub­lished results of a major clinical trial investi­gat­ing the efficacy and safety of Pomalyst (poma­lido­mide, Imnovid) and dexa­metha­sone in multiple myeloma patients who have had many prior ther­apies.

Results of the trial, known as the STRATUS (MM-010) study, have pre­vi­ously been presented at several major medical meetings. This is the first time, how­ever, that the results have been summarized in a journal article.

The new efficacy and safety results are in line with previously published results of other trials testing the combination of Pomalyst …

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion, recommending against the authori­za­tion of NINLARO® (ixazomib) capsules, an oral pro­te­a­some inhibitor for the treat­ment of patients with re­lapsed and/or refractory multiple myeloma. Takeda intends to appeal this opinion and request a re-examination by the CHMP.

“We are disappointed by the CHMP’s opinion. With the sup­port of European key medical experts, we will con­tinue our efforts work­ing …

Pivotal Head-to-Head ENDEAVOR Study Shows Kyprolis Plus Dexamethasone Doubled Progression-Free Survival Compared to Velcade® (Bortezomib) and Dexamethasone

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current indi­ca­tion for Kyprolis® (car­filz­o­mib) to in­clude treat­ment in com­bi­na­tion with dexa­meth­a­sone alone for adult patients with multiple myeloma who have received at least one prior ther­apy.

"In the first ever comparative Phase 3 head-to-head study of two pro­te­a­some inhibitors in re­lapsed multiple myeloma, Kyprolis in com­bi­na­tion with dexa­meth­a­sone nearly doubled pro­gres­sion-free survival compared to a current …