NINLARO Provides a New Option for Patients Living with Multiple Myeloma Who Have Received at Least One Prior Therapy

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved NINLARO^® (ixazomib) capsules, the first and only oral pro­te­a­some inhibitor, indicated in com­bi­na­tion with lena­lido­mide and dexa­metha­sone for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy. NINLARO is a once-weekly pill. More in­­for­ma­tion is avail­able at www.NINLARO.com.

Takeda submitted a New Drug Application for NINLARO to the FDA in July 2015, and in September NINLARO was granted Priority Review …

Silver Spring, MD (Press Release) – On November 20, 2015, the U.S. Food and Drug Admin­istra­tion approved ixazomib (NINLARO, Millennium Pharma­ceu­ticals, Inc., a wholly owned sub­sid­i­ary of Takeda Pharma­ceu­ti­cal Company Limited) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy. Ixazomib is the first approved oral pro­te­a­some inhibitor.

The approval was based on an im­prove­ment in pro­gres­sion- free survival (PFS) in a multi­center, ran­dom­ized, double-blind, placebo-controlled trial enrolling 722 patients with multiple myeloma who had received 1 to 3 …

Silver Spring, MD (Press Release) – Today the U.S. Food and Drug Admin­istra­tion granted approval for Ninlaro (ixazomib) in com­bi­na­tion with two other ther­a­pies to treat people with multiple myeloma who have received at least one prior ther­apy.

Multiple myeloma is a form of blood cancer that occurs in in­fec­tion-fighting plasma cells (a type of white blood cell) found in the bone marrow. These can­cer­ous cells multiply, produce an ab­nor­mal protein and push out other healthy blood cells from the bone marrow. The disease may result in a weakened immune system and …

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Priority Review status to the New Drug Application (NDA) for ixazomib, the first inves­ti­ga­tional oral pro­te­a­some inhibitor for the treat­ment of patients with re­lapsed and/or refractory multiple myeloma.

“We are encouraged that both the U.S. and European regu­la­tory bodies have determined that the ixazomib appli­ca­tions qualify for an expedited review, underscoring the importance of new treat­ment options for patients with re­lapsed / refractory multiple myeloma,” said Melody …

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Med­i­cines Agency (EMA) has granted an accelerated assess­ment to ixazomib, an inves­ti­ga­tional oral pro­te­a­some inhibitor for the treat­ment of patients with re­lapsed and /or refractory multiple myeloma. The EMA awards an accelerated assess­ment to those medicines deemed to be of major public health interest and, in particular, thera­peutic inno­va­t.

Takeda ex­pec­ts to submit a market­ing authori­za­tion appli­ca­tion for ixazomib in the European Union …

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that a New Drug Application (NDA) has been submitted to the United States (U.S.) Food and Drug Admin­istra­tion (FDA) for ixazomib, an inves­ti­ga­tional oral pro­te­a­some inhibitor for the treat­ment of patients with re­lapsed and/or refractory multiple myeloma.

The NDA sub­mission was based on the pivotal Phase 3 trial TOURMALINE-MM1, an inter­na­tional, ran­dom­ized, double-blind, placebo controlled clin­i­cal trial of 722 patients designed to eval­u­ate the superiority of ixazomib plus lena­lido­mide and dex­a­meth­a­sone over placebo plus lena­lido­mide and …

Takeda Oncology gab positive Resultate einer wichtigen Studie bekannt, die die Substanz Ixazomib bei rezidivierten Myelompatienten geprüft hat.

Die Teilnehmer der großen Phase 3 Ixazomib-Studie, die auch als TOURMALINE MM-1 Studie bekannt ist, erhielten eine von zwei möglichen Behandlungen. Eine Gruppe wurde mit Ixazomib, Revlimid (Lenalidomid) und Dexamethason behandelt, während die andere Gruppe ein Placebo (Zuckerpille), Revlimid und Dexamethason erhielt.

Die Studienleiter führten die erste geplante Zwischenanalyse der Studienergebnisse durch. Takeda zufolge zeigte die Analyse, dass Patienten in der Studie, die Ixazomib erhielten, ein längeres progressionsfreies Überleben hatten als diejenigen im Placeboarm …