TOURMALINE-MM2 Data Presented Virtually at the Society of Hema­to­logic Oncology (SOHO) Eighth Annual Meeting

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Com­pany Limited (TSE:4502/NYSE:TAK) (“Takeda”) to­day an­nounced re­­sults from the Phase 3 TOUR­MA­LINE-MM2 trial eval­u­ating the addi­tion of NIN­LARO™ (ix­az­o­mib) to lena­lido­mide and dexa­meth­a­sone versus lena­lido­mide and dexa­meth­a­sone plus placebo in newly diag­nosed mul­ti­ple myeloma patients not eli­gible for au­tol­o­gous stem cell trans­plant. These data will be pre­sented at the virtual sci­en­tif­ic meeting of the Society of Hema­to­logic Oncology (SOHO) on Wednesday, Sep­tem­ber 9, 2020 at 6:15 p.m. CT.

The study found the addi­tion of NIN­LARO to lena­lido­mide and dexa­meth­a­sone re­­sulted in a 13.5 …

Approval broadens DAR­ZA­LEX label to in­clude fifth treat­ment op­tion in the re­lapsed / re­frac­tory setting and rep­re­sents the eighth ap­prov­ed in­di­ca­tion for DAR­ZA­LEX

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the U.S. Food and Drug Admin­istra­tion (FDA) ap­prov­al of DAR­ZA­LEX® (dara­tu­mu­mab) in com­bi­na­tion with Kyprolis® (car­filz­o­mib) and dexa­meth­a­sone (DKd) for the treat­ment of adult patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who have re­ceived one to three pre­vi­ous lines of ther­apy. DAR­ZA­LEX® has been ap­prov­ed in com­bi­na­tion with two car­filz­o­mib dosing regi­mens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on pos­i­tive re­­sults from the Phase 3 CANDOR and Phase 1b EQUULEUS stud­ies, rep­re­senting the first-ever ap­prov­al of an …

• DARZALEX® (dara­tu­mu­mab) ap­prov­ed by U.S. FDA in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone for the treat­ment of adult patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who have re­ceived one to three pre­vi­ous lines of ther­apy
• Approval based on the Phase 3 CANDOR study
• Approval marks eighth U.S. FDA ap­prov­al for DAR­ZA­LEX

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has ap­prov­ed the use of DAR­ZA­LEX® (dara­tu­mu­mab) in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone (DKd) for the treat­ment of adult patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who have re­ceived one to three pre­vi­ous lines of ther­apy. A supple­mental Biologics License Appli­ca­tion (sBLA) for this in­di­ca­tion was sub­mitted by Genmab’s licensing part­ner, Janssen Bio­tech, Inc. (Janssen), in Feb­ru­ary 2020. In August 2012, Genmab granted …

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) to­day an­nounced that the U.S. District Court in Delaware issued a de­ci­sion upholding the validity of pat­ent claims from three pat­ents that pro­tect Amgen's multiple myeloma ther­apy KYPROLIS® (car­filz­o­mib). Today's de­ci­sion will prevent Cipla Limited, and Cipla USA, Inc. (collectively "Cipla") from making, using, selling, offering to sell, or importing its generic version of KYPROLIS until expiration of these three U.S. pat­ents. The latest pat­ent expiry is in De­cem­ber 2027.

Onyx Thera­peutics, Inc., an indirect, wholly-owned sub­sid­i­ary of Amgen Inc., brought a pat­ent in­fringe­ment suit …

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Com­pany Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the results from the TOURMALINE-MM2 study designed to eval­u­ate the addi­tion of NIN­LARO™ (ixazomib) to lena­lido­mide and dexa­meth­a­sone in newly diag­nosed trans­plant in­eli­gible multiple myeloma patients. The addi­tion of ixazomib to lena­lido­mide and dexa­meth­a­sone resulted in an im­prove­ment in median pro­gres­sion-free sur­vival (PFS) of 13.5 months (35.3 months versus 21.8 months; hazard ratio [HR] 0.83; p=0.073); how­ever, it did not meet the threshold for statistical sig­nif­i­cance. The safety profile asso­ci­ated with NIN­LARO from the TOURMALINE-MM2 trial was …

Application is based on pos­i­tive data from the Phase 3 CANDOR study, which were pre­sented at the 2019 American Society of Hematology Annual Meeting

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with Kyprolis® (car­filz­o­mib) and dexa­meth­a­sone (DKd) for re­lapsed / re­frac­tory multiple myeloma. The sBLA is sup­ported by results from the Phase 3 CANDOR study, which com­pared treat­ment with DKd to car­filz­o­mib and dexa­meth­a­sone (Kd) in patients with multiple myeloma who re­lapsed after one to three prior lines of ther­apy.

"While we con­tinue to …

• Results Demonstrated Statistically Significant Improvement in Progression-Free Survival
• Data to be Submitted for Presentation at an Upcoming Medical Meeting

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Com­pany Limited (TSE: 4502/NYSE: TAK) ("Takeda") today announced the ran­dom­ized, Phase 3 TOURMALINE-MM4 study met its pri­mary end­point of pro­gres­sion free sur­vival (PFS). The trial eval­u­ated the effect of single-agent oral NIN­LARO™ (ixazomib) as a first line main­te­nance ther­apy versus placebo in adult patients diag­nosed with multiple myeloma not treated with stem cell trans­plan­ta­tion. TOURMALINE-MM4 is the first industry sponsored Phase 3 trial to explore the concept of “switch” main­te­nance, the use of med­i­cines …