Osaka, Japan, May 24, 2017 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that NINLARO® capsules (generic name: ixazomib, development code: MLN9708, hereinafter: "NINLARO") are now available in Japan. NINLARO is the first oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone, for which Takeda has obtained the New Drug Application Approval for the treatment of patients with relapsed or refractory multiple myeloma.
The approval of the drug is based on safety and efficacy data from TOURMALINE-MM1, a global Phase 3 clinical trial in patients with relapsed or refractory multiple myeloma. The trial demonstrated a statistically significant and clinically meaningful improvement (35%) in the length of progression free survival (PFS) as a primary endpoint by administering NINLARO in combination with lenalidomide and dexamethasone when compared with placebo in combination with lenalidomide and dexamethasone (hazard ratio = 0.74, p = 0.01, median PFS = 20.6 months in the ixazomib group vs. 14.7 months in the control group, median follow-up period = 14.7 months). The results also demonstrated that the all-oral triplet regimen containing NINLARO had a manageable tolerability and safety profile.
“Patients with multiple myeloma have many unmet medical needs including continuation of treatment, alleviation of adverse drug reactions, and reduction of the burden of hospital visits,” said Tsudoi Miyoshi, Head of Japan Oncology Business Unit of Takeda. “The launch of NINLARO may make the all-oral triplet regimen available to the patients as well as contribute to their unmet medical needs by once-weekly administration demonstrating manageable tolerability.”
About NINLARO® (ixazomib) capsules
Name of the product
NINLARO® Capsules 2.3 mg
NINLARO® Capsules 3 mg
NINLARO® Capsules 4 mg
Relapsed or refractory multiple myeloma
<Precautions related to indication>
(2) Patients for whom NINLARO is indicated should be selected with a thorough knowledge of the contents in the section of [Clinical Studies] (which are stated on the package insert) for the treatment history, etc. of patients who were enrolled in the clinical trials, and an adequate understanding of the efficacy and safety of NINLARO.
Dosage and administration
In combination therapy with lenalidomide and dexamethasone, the usual adult dose is 4 mg/day as ixazomib administered orally during fasting once weekly for 3 weeks (Days 1, 8, and 15), followed by a 13-day withdrawal period (Days 16 to 28). This 4-week cycle should be repeated. The dose should be reduced appropriately according to the condition of the patient.
NINLARO® Capsules 2.3 mg : 96,519.00 yen
NINLARO® Capsules 3 mg : 123,355.60 yen
NINLARO® Capsules 4 mg : 160,886.00 yen
NINLARO® (ixazomib) is an oral proteasome inhibitor, which is also being studied across the continuum of multiple myeloma treatment settings as well as systemic light-chain (AL) amyloidosis. There are 40 total countries approved including U.S. and Europe. Takeda has submitted marketing authorization applications for NINLARO to a number of additional regulatory authorities around the world.
Ixazomib was granted orphan drug designation in multiple myeloma in both the U.S. and Europe in 2011 and for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory systemic light-chain (AL) amyloidosis in 2014.
About Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of monoclonal plasma cells, or myeloma cells, becomes cancerous and multiplies. These malignant plasma cells have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting immune system, kidneys and red blood cell count, with some of the more common symptoms including fatigue or anemia. Multiple myeloma is a rare form of cancer, with 114,000 new cases globally per year.
About TOURMALINE Trials
The examination of safety, efficacy, etc. through comprehensive ixazomib clinical development program, TOURMALINE, further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. TOURMALINE includes a total of five ongoing pivotal trials – four, which together are investigating every major multiple myeloma patient population, and one in light-chain amyloidosis:
In addition to the TOURMALINE program, ixazomib is being evaluated in multiple therapeutic combinations for various patient populations in investigator initiated studies globally.
About Orphan Drug Designation
NINLARO® capsules was granted orphan drug designation for the treatment of patients with relapsed or refractory multiple myeloma by the Minister of Health, Labour and Welfare in February 2016. For additional information on Orphan Drug Designation, please visit the following press release dated February 26, 2016.
The drug information contained herein is intended to disclose Takeda's corporate information. Nothing contained herein should be considered a solicitation, promotion or indication for any prescription drug including the ones under development.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom/.
Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website, www.takedaoncology.com.
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