The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of Takeda’s Alunbrig (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Alunbrig is a tyrosine kinase inhibitor (TKI)…
Takeda’s Phase 3 Trial Of Alunbrig Met Primary Endpoint
Takeda Pharmaceutical Company announced that the global, randomized, Phase 3 ALTA-1L (ALK in Lung Cancer Trial of AP26113 in 1st Line) trial met its primary endpoint at the first pre-specified interim analysis, with Alunbrig (brigatinib) demonstrating a statistically significant improvement in progression-free survival (PFS) compared to crizotinib in adults with anaplastic lymphoma kinase-positive (ALK+) locally advanced or metastatic non-small cell lung…
Takeda Multiple Myeloma Post-Transplant Therapy Meets Primary Endpoint
Takeda Pharmaceutical Company Limited announced that the randomized Phase 3 TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral Ninlaro (ixazomib) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) versus placebo. The trial evaluated the effect of Ninlaro as a maintenance therapy in adult patients diagnosed with multiple myeloma who…
Takeda and Zinfandel Pharmaceuticals Discontinue Alzheimer’s-Related Trial
Takeda and Zinfandel Pharmaceuticals discontinue ‘TOMMORROW’ trial following planned futility analysis. Takeda Pharmaceutical Company Limited and Zinfandel Pharmaceuticals, Inc. have discontinued the global Phase III TOMMORROW trial. The decision to discontinue the trial was based on a planned interim futility analysis, which showed an inadequate treatment effect with the investigational drug pioglitazone 0.8 mg SR in delaying…
Takeda And Denali Collaborating To Develop Neurodegenerative Disease Therapies
Takeda and Denali Therapeutics collaborate to develop and commercialize therapies for neurodegenerative diseases. Takeda Pharmaceutical Company Limited and Denali Therapeutics have entered into a strategic option and collaboration agreement to develop and commercialize up to three specified therapeutic product candidates for neurodegenerative diseases. Each program is directed to a genetically validated target for neurodegenerative disorders, including Alzheimer’s…
