Takeda Announces China Approval of Ninlaro® (Ixazomib), Ushering in an All-Oral Treatment Era for Multiple Myeloma

- Clinical ResearchData Prove that Ninlaro^®(Ixazomib)Lenalidomide and Dexamethasone Combination（IRd）Can significantly shorten the onset time,Prolonging Patient SurvivalUp to 10 months^[1]
- Ixazomib-based combination therapy has become China’s first all-oral regimen containing a proteasome inhibitor, significantly enhancing medication convenience and treatment adherence for patients.
- The latest revised version released at the end of 2017, “Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma》Has beenNinlaro^®(Ixazomib) Combination Regimen (IRd) Included in the recommended treatment regimens for relapsed multiple myeloma^[2]
- Ninlaro^®(Ixazomib)AcquisitionGranted by the China Food and Drug Administration (CFDA)Priority Review Designation^[3]

Shanghai, April 17, 2018 /PRNewswire/ -- Today, Takeda China officially announced Ninlaro^®(Ixazomib) has been approved by the China Food and Drug Administration (CFDA) for use in combination with lenalidomide and dexamethasone as the first all-oral regimen for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

The approval of ixazomib this time is based on a study named TOURMALINE-MM1^[4]Phase III clinical trial results. The results of both the global study and the China extension study demonstrated that, for relapsed and/or refractory multiple myeloma, the ixazomib combined with lenalidomide and dexamethasone treatment group (IRd) compared to the placebo combined with lenalidomide and dexamethasone control group (Rd):

Multiple myeloma is a malignant hematologic tumor caused by pathological changes in bone marrow plasma cells and remains incurable.^[9], and prone to recurrence^[10]. This disease is more common in the elderly^[11], leading to bone marrow failure, bone destruction, hypercalcemia, anemia, infection, renal failure, and neurological symptoms, which threaten patients' long-term survival. The incidence of multiple myeloma in China is approximately 1 per 100,000 population.^[12], surpassing acute leukemia to rank second among hematologic malignancies^[13], approximately 18 people die from multiple myeloma each day^[14]. As China gradually transitions into an aging society with a continuously growing elderly population, the incidence of multiple myeloma in China is expected to rise further.

"Multiple myeloma is a progressive cancer characterized by relapse, and patients are eagerly anticipating better treatment options to adhere to long-term therapy. In the 2017 latest revised 'Chinese Guidelines for Diagnosis and Treatment of Multiple Myeloma,' ixazomib has become a recommended treatment option for second-line therapy in myeloma patients. Today, ixazomib has officially received approval from the CFDA, which is undoubtedly good news for patients," pointed out Professor Hou Jian, Lead Principal Investigator (LPI) of the TOURMALINE-MM1 China extension study, member of the International Myeloma Working Group (IMWG), Chairman of the Hematology Branch of the Shanghai Medical Association, and Director of the Department of Hematology at Renji Hospital in Shanghai. "As the world’s first oral proteasome inhibitor..."^[15]“, the ixazomib-based combination regimen has ushered in a new era of all-oral therapy for patients with multiple myeloma. This has significantly enhanced the convenience and adherence of treatment, playing a crucial role in helping patients maintain long-term therapy and achieve durable remission.”

Mr. Shan Guohong, Head of Takeda’s Greater China Region and President of Takeda China, stated, “Takeda remains committed to accelerating the availability of global innovative medicines for patients in China. In China, we actively support the conduct of international multicenter clinical trials, and the high-quality clinical research data from China have not only supported Enlaze^®The successful approval in the EU also helped Ninlaro^®Granted priority review status by the CFDA. Since Takeda launched the world’s first proteasome inhibitor^[16], to the world's first oral proteasome inhibitor, Enleirei^[17]“We remain committed to improving treatment outcomes and the therapeutic experience for patients with multiple myeloma. Moving forward, we will continue to actively collaborate with stakeholders across society to help more patients with multiple myeloma achieve long-term survival through innovative therapies.”

As a global pharmaceutical company dedicated to research and development, Takeda has been committed to the field of oncology for over 25 years. It has achieved remarkable success in hematologic malignancies, including multiple myeloma, Hodgkin lymphoma, and acute myeloid leukemia. In the realm of solid tumors, Takeda is also actively exploring a series of revolutionary therapies, such as innovative targeted drugs and next-generation CAR-T cell therapies. Looking ahead, Takeda will continue to intensify its drug development and innovation in oncology, providing more advanced medical solutions for patients globally and in China, thereby benefiting more patients and their families.

About Multiple Myeloma

Multiple Myeloma (MM) is a plasma cell neoplasm that originates in the bone marrow. In multiple myeloma, a clone of monoclonal plasma cells (or myeloma cells) transforms into malignant cells and proliferates. These malignant plasma cells may involve most bones in the body, potentially leading to compression fractures, lytic bone lesions, and associated bone pain. Multiple myeloma can cause numerous serious health complications affecting the bones, immune system, kidneys, and red blood cell count. Common symptoms include hypercalcemia, renal impairment, anemia, and bone disease. Multiple myeloma is a rare cancer, with approximately 114,000 new cases diagnosed globally each year as of 2012.^[18]。