武田薬品工業株式会社
Takeda today announced the launch of oral proteasome inhibitor “NINLARO® Capsules 0.5 mg” (generic name: ixazomib citrate, “NINLARO 0.5 mg”) in Japan. This release adds a new dosage form to the existing NINLARO® Capsules (2.3 mg, 3 mg and 4 mg) and offers patients a new treatment option for maintenance therapy in multiple myeloma with a lower dose formulation of NINLARO (1.5 mg dose using three 0.5 mg capsules).
NINLARO 0.5 mg was submitted for marketing authorization to the Ministry of Health, Labour and Welfare in September 2023, based primarily on the results of the TOURMALINE-MM3 and TOURMALINE-MM4 trials, which were international, randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical studies. Marketing approval was granted by the Ministry of Health, Labour and Welfare on August 13, 2024.
“With this lower dosage formulation, we aim to provide more dose adjustments options tailored to the condition of patients undergoing maintenance therapy with NINLARO. We remain committed to address the medical needs of patients and healthcare professionals.” said Satoshi Uchida, Head of Japan Oncology Business Unit at Takeda.
NINLARO® received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare in March 2017 for the indication of “relapsed or refractory multiple myeloma” and was launched on May 24, 2017. Takeda also received approval for a partial change to the manufacturing and marketing approval for NINLARO® for the additional indications of “maintenance therapy after autologous hematopoietic stem cell transplantation in multiple myeloma” in March 2020, and as a “maintenance therapy after initial therapy for multiple myeloma without prior stem cell transplantation” in May 2021. In August 2024, NINLARO® Capsules 0.5 mg was approved by the Ministry of Health, Labour and Welfare for maintenance therapy in multiple myeloma.
The TOURMALINE-MM3 trial is a randomized, placebo-controlled, double-blind, multicenter phase 3 study of 656 patients. The study targeted multiple myeloma patients who showed a response (complete response (CR), very good partial response (VGPR), or partial response (PR)) to induction therapy, subsequent high-dose chemotherapy, and autologous stem cell transplantation. The trial primarily evaluated the efficacy and safety of NINLARO as maintenance therapy in comparison to placebo, with progression-free survival (PFS) as the primary endpoint. An important secondary endpoint was overall survival (OS). In this trial, NINLARO demonstrated a statistically significant improvement in PFS compared to the placebo group, showing a 39% improvement. Additionally, the safety profile of NINLARO in maintenance therapy was consistent with its known safety profile. These results were published in The LANCET.1
TOURMALINE-MM4 is a randomized, double-blind, placebo-controlled, multicenter international Phase 3 study of 706 patients, designed to evaluate the effect of single-agent oral NINLARO as a maintenance therapy following primary therapy in adult patients diagnosed with multiple myeloma who have not received a stem cell transplant. This is the first company-led Phase III trial to evaluate switch maintenance, in which maintenance therapy is given to patients who did not receive initial induction therapy. The primary endpoint was progression-free survival (PFS), and the study demonstrated a statistically significant improvement in this metric. The safety profile of NINLARO as a maintenance therapy is similar to the known safety profile of monotherapy, and no new concerns were identified in the TOURMALINE-MM4 study. These results were published in Journal of Clinical Oncology.2
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
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