Business Wire

Takeda Launches Largest Pharmaceutical Company-Sponsored Global Observational Study of Its Kind in Multiple Myeloma


Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that its global non-interventional, observational multiple myeloma study is now enrolling patients. Titled INSIGHT-MM, the study aims to enroll 5,000 patients over three years with a goal of following each patient for a minimum of five years in an effort to track patterns in disease presentation, patient characteristics, treatment and outcomes and thereby enhance the understanding of real world experience of patients with multiple myeloma.

“As both a physician and a patient, I have seen – and experienced – rapid changes in the approach to multiple myeloma treatment. Even with the recent introduction of new therapies, more work needs to be done to improve outcomes for patients across the globe,” said Jim Omel, M.D., INSIGHT-MM Steering Committee member, who was diagnosed with multiple myeloma in 1997. “The INSIGHT-MM study gives the community an opportunity to work together to better understand how clinical advances affect multiple myeloma patients in the real world.”

“In relatively rare diseases, such as multiple myeloma, we often lack access to large datasets that can help inform decisions in our practices,” said Faith Davies, M.D., Professor of Medicine and Medical Director, Myeloma Institute, University of Arkansas for Medical Sciences, INSIGHT-MM Steering Committee Co-Chair. “By gathering comprehensive real world data on this scale, we will have the opportunity to identify best practices from across the globe to help us better understand what works and what doesn’t for specific patients. These learnings can in turn enhance our efforts to improve disease management for people living with multiple myeloma.”

Study sites at the University of Arkansas for Medical Sciences; the University of California, San Diego; and the University of Cincinnati Cancer Institute – the first three of an anticipated more than 150 global locations – are now active and have enrolled the first patients in the study. Led by an international steering committee of myeloma experts, the INSIGHT-MM study will gather data via routine office visits, medical records and patient self-reported outcomes. Participation in INSIGHT-MM, a non-interventional study, will not determine or alter patients’ treatment; rather, patients will receive their usual therapy as determined by their healthcare provider during the course of their care. Designed to be collaborative, INSIGHT-MM remains open for the multiple myeloma community to propose analyses and request data that has been collected during the study.

“At Takeda Oncology, we have worked with the multiple myeloma community for the benefit of patients for nearly two decades. Given the increased complexity of treatment in recent years, we saw the need to understand treatment patterns and patients’ experiences around the world,” said Liviu Niculescu, Vice President Global and US Medical Affairs, Takeda Oncology. “With patients and multiple myeloma experts, we designed the innovative INSIGHT-MM trial to be an open source of data – large enough to reveal differences and trends globally. We invite collaborations from other similar studies in order to increase the size of available databases and move us closer to a future when robust data on multiple myeloma enables us to change the face of the disease.”

The INSIGHT-MM study is currently enrolling patients in the United States and will soon be enrolling patients globally. The following countries are participating in the INSIGHT-MM study: The United States, the United Kingdom, Germany, Italy, Spain, Brazil, Israel, France, Belgium, Greece, Mexico, China, Taiwan, Colombia and Turkey. To learn more, please visit

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 30,000 new cases in the US, 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

Additional information about Takeda is available through its corporate website,, and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website,

Contact information

Takeda Pharmaceutical Company Limited
Japanese Media
Tsuyoshi Tada, +81 (0) 3-3278-2417
Media outside Japan
Amy Atwood, +1-617-444-2147

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Seoul Semiconductor’s SunLike Series LEDs Win Product of the Year Award from Elektronik Magazine23.3.2018 18:28Pressemelding

Seoul Semiconductor, a global innovator of LED products and technology, announced on March 23rd that its SunLike Series natural spectrum LED product won the Gold Award at the Elektronik Product of the Year 2018 Awards, hosted by Elektronik (, a leading German electronics publication. This press release features multimedia. View the full release here: Product of the Year Award from Elektronik Magazine (SunLike) (Photo: Business Wire) As a publication specializing in electrical and electronic components, “Elektronik” is a prestigious magazine with an illustrious history and the largest number of subscribers in Germany. Over the past 20 years, they have conducted annual surveys among their subscribers to find the “most creative and innovative products.” Based on these survey results, Elektronik selects the top product that with the most impact in its corresponding field, and confers the awards accordingl

Elliott Welcomes Imminent Bezeq Board Overhaul and New Era for Strong Independent Governance23.3.2018 16:05Pressemelding

Elliott Advisors (UK) Limited (“Elliott”), which advises funds which collectively hold a significant economic interest in Bezeq The Israeli Telecommunication Corporation Ltd. (“Bezeq” or the “Company”), welcomes the proposed governance reforms announced by Bezeq last night. In its initial letter to Bezeq Interim Chairman David Granot, dated January 16, 2018, Elliott outlined the urgent need to address the Company’s serious corporate governance issues, and called for changes at the Board level that result in “the right mixture of expertise, independence and integrity for the future.” Elliott stated then, and reiterates now, its belief that “there is significant value to be unlocked if the right steps are taken to improve its corporate governance.” Bezeq has strong business fundamentals, an exemplary workforce, and great potential. Following yesterday’s announcement, Elliott highlights the changes that have occurred since January 16th. Taken together, these amount to a revolution in the

Clovis Oncology Initiates Early Access Program for Rucaparib as Treatment and as Maintenance Therapy in Recurrent Ovarian Cancer in Europe23.3.2018 12:52Pressemelding

Clovis Oncology, Inc. (NASDAQ:CLVS) today announced the initiation of an early access program in Europe for rucaparib for treatment and as maintenance therapy in recurrent ovarian cancer. The program will be overseen and implemented by Caligor Coghlan, which specializes in early access to medicines. The program, to be known as the Rucaparib Access Program (RAP), will enable participation from certain countries in Europe, where permitted by applicable rules, procedures and regulatory authorities. The RAP protocol allows for rucaparib treatment of an individual patient with third-line or greater BRCA mutant epithelial, fallopian tube, or primary peritoneal ovarian cancer who has platinum-sensitive disease and is unable to tolerate further platinum-based chemotherapy or has platinum-resistant disease and needs treatment with single agent rucaparib. The RAP protocol will also provide access to rucaparib for maintenance therapy of an individual patient with recurrent epithelial ovarian, fal

CHMP Grants Positive Opinion for Clovis Oncology’s Rubraca® (rucaparib) Tablets23.3.2018 12:50Pressemelding

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a conditional marketing authorization for Rubraca as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy. The European Marketing Authorization application for the treatment indication was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA mutant ovarian cancer who had progressed after two or more prior chemotherapies. “The recommendation

Janssen Announces Positive CHMP Opinion for JULUCATM▼ (dolutegravir/rilpivirine)23.3.2018 12:46Pressemelding

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for JULUCA™ (dolutegravir 50mg [ViiV Healthcare UK Ltd]/rilpivirine 25mg [Janssen Sciences Ireland UC]). Dolutegravir/rilpivirine is a single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI).1 “We are delighted to be one step closer to bringing JULUCA™ to people living with HIV in Europe,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. “Building on our 25-year c

Aitheon Executives Educate World Leaders on Benefits, Challenges of AI at the Annual World Government Summit in Dubai23.3.2018 12:00Pressemelding

Aitheon, makers of the world’s first blockchain-powered platform to solve real problems by integrating AI, robotics, IoT, human specialists and cryptocurrency, announced today that executives from the company held a series of high-level briefings with world leaders at the Annual World Government Summit in Dubai. Briefings covered the benefits and challenges of AI, and revolutionary new solutions to world challenges made possible by transformative new technologies. (Read the full release at This press release features multimedia. View the full release here: Aitheon founder and CEO, Andrew Archer, and Chief Strategy Officer, Ryan Burleson, were invited to brief leaders at the Summit by Cyrus Hodes, Co-founder and Director of the AI Initiative, an undertaking of the Future Society at Harvard University’s Kennedy School. Archer and Burleson addressed a variety of AI-related topics, including the impact of AI on