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Takeda Pharmaceutical Company Limited announced that the EC has granted conditional marketing authorization for NINLAROTM （ixazomib）capsules, indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy.
The decision to approve NINLARO as the first and only oral proteasome inhibitor to treat multiple myeloma follows a positive opinion by the European Medicines Agency EMA） Committee for Medicinal Products （CHMP） for Human Use in September 2016.“For myeloma patients living in Europe, the approval of NINLARO means we have a new and effective treatment option available when we relapse,” said Bob Munro, a patient with multiple myeloma from the United Kingdom.
“I applaud the European Commission for recognising the additional benefit that NINLARO will bring to patients, who not only want treatment options that are effective and tolerable, but also appreciate the convenient option of taking an oral treatment. I strongly hope this will be made available by national health systems across Europe as soon as possible.”
The European Commission followed the CHMP’s recommendation to approve NINLARO based on data from the pivotal Phase 3 TOURMALINE-MM1 trial, which demonstrated that NINLARO plus lenalidomide and dexamethasone increased the length of progression-free survival by about six months, or 40 percent, in patients with relapsed and refractory multiple myeloma when compared with placebo, lenalidomide and dexamethasone. The study also showed that the progression-free survival benefit observed in the NINLARO regimen extended across pre-specified subgroups of patients. Follow-up analyses for overall survival are planned for 2017.
“With the approval of NINLARO by the European Commission, physicians across the region will have the option to prescribe an all-oral triplet regimen to treat patients with multiple myeloma who have received at least one prior therapy,” said Philippe Moreau, MD, Head of the Hematology Department at the University Hospital of Nantes, France. “In the TOURMALINE-MM1 study, we saw a clinically meaningful six-month improvement in progression-free survival with NINLARO, evidence that has supported its approval in Europe. As a hematologist, I welcome the availability of this treatment to address a devastating disease like multiple myeloma.”
“When developing NINLARO, Takeda Oncology’s scientists sought to formulate an efficacious and unique oral proteasome inhibitor with a manageable safety profile. NINLARO delivers the proven efficacy of a proteasome inhibitor in a convenient once-weekly pill that can be taken at home,” said Christophe Bianchi, M.D., President, Takeda Oncology. “NINLARO has the potential to help European patients with relapsed multiple myeloma by removing some of the barriers that can stand in the way of optimal treatment. With NINLARO, our hope is that many patients will be able to continue therapy until disease progression. Following the European Commission’s approval, we will continue to study NINLARO in a variety of settings in the hopes that we can bring this medicine to as many of the patients who may benefit from it as possible.”
As a result of the European Commission decision, NINLARO is now approved for use across the European Economic Area, which includes the European Union’s 28 member states as well as Norway, Liechtenstein and Iceland. In addition, NINLARO is licensed for use in the U.S., Canada, Israel, Australia and Venezuela, and Takeda has submitted marketing authorization applications for NINLARO to a number of additional regulatory authorities around the world.
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 the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer, with approximately 39,000 new cases in the EU and 114,000 new cases globally per year.
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. More than 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 http://www.takeda.com/news
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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