Articles tagged with: Ninlaro
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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 …
Press Releases»
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 …
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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 …
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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 …
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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 …
Press Releases»

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 …
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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 …