CAMBRIDGE, MASS. & OSAKA, JAPAN--( / ) April 29, 2016 -- Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that results from the international, randomized, double-blind, placebo-controlled TOURMALINE-MM1 Phase 3 clinical study, evaluating once-weekly oral NINLARO® (ixazomib) capsules plus lenalidomide and dexamethasone versus placebo plus lenalidomide-dexamethasone in patients with relapsed and/or refractory multiple myeloma, have been published in the prestigious New England Journal of Medicine (NEJM). NINLARO was recently approved by the U.S. Food and Drug Administration (FDA), based on the pivotal TOURMALINE-MM1 data, in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
This Smart News Release features multimedia. View the full release here:
“NEJM has published the results of the first Phase 3 study supporting an all-oral triplet regimen containing a proteasome inhibitor in multiple myeloma. With the emergence of long-term treatment as a preferred approach for multiple myeloma, it is crucial that we investigate more ways to improve treatment sustainability for patients,” said study co-author and lead investigator Philippe Moreau, M.D., University of Nantes, France. “The TOURMALINE-MM1 results demonstrated that ixazomib in combination with lenalidomide and dexamethasone is an effective and tolerable oral regimen with a manageable safety profile for patients with relapsed and/or refractory multiple myeloma.”
“The publication of the Phase 3 TOURMALINE-MM1 trial results is another important milestone for patients and physicians. This reflects invaluable efforts from our researchers, the study investigators, the patients and their families,” said Dixie-Lee Esseltine, MD, FRCPC, Vice President, Oncology Clinical Research, Takeda. “The publication concluded that the addition of ixazomib to lenalidomide and dexamethasone was associated with significantly longer progression-free survival; the additional toxic effects with this all-oral regimen were limited. We look forward to sharing additional ixazomib data from our ongoing TOURMALINE studies over the next few years.”
TOURMALINE-MM1, a double-blind, placebo-controlled trial including 722 patients, is the first Phase 3 study with an oral proteasome inhibitor. As reported in NEJM, the trial results demonstrated a statistically significant and clinically meaningful (35%) extension of PFS (HR 0.74; p = 0.01; median PFS: 20.6 months vs. 14.7 months in control group; median follow-up 14.7 months). A benefit in PFS was observed with the ixazomib regimen across pre-specified patient subgroups, including patients with poor prognosis, such as elderly patients, those who have received two or three prior therapies, those with advanced stage disease, and those with high-risk cytogenetic abnormalities. Overall response rates were 78% in the ixazomib arm versus 72% in the placebo group and at least very good partial response rates were 48% versus 39%. The median time to response was 1.1 months in the ixazomib arm versus 1.9 months in the placebo group, and median duration of response was 20.5 versus 15.0 months, respectively. In the ixazomib and placebo groups, frequencies of serious adverse events (47% vs. 49%) and on-study deaths (4% vs. 6%) were similar; 74% and 69% of patients experienced grade ≥3 adverse events. Grade 3 and 4 thrombocytopenia was more frequent in the ixazomib (12 and 7%) vs. placebo group (5 and 4%). Rash occurred more frequently in the ixazomib group than in the placebo group (36% vs. 23% of the patients), as did gastrointestinal adverse events, which were predominantly low grade. The incidence of peripheral neuropathy was 27% in the ixazomib group and 22% in the placebo group (grade 3 events occurred in 2% of the patients in each study group, and no grade 4 events were reported). Please see below for the full U.S. prescribing information of NINLARO (ixazomib) capsules.
Data from TOURMALINE-MM1 were previously presented at the 57th Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida.
NINLARO is currently under review by the European Medicines Agency (EMA). Takeda has also submitted applications for approval of ixazomib to additional health authorities around the world.
About NINLARO (ixazomib) capsules
NINLARO (ixazomib) is the first and only oral proteasome inhibitor approved by the U.S. Food and Drug Administration (FDA) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is administered orally, once-weekly 4 mg fixed dose on days 1, 8, and 15 of a 28-day treatment cycle. NINLARO also received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory systemic light-chain (AL) amyloidosis, a related ultra orphan disease, in 2014.
The 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 investigating every major multiple myeloma patient population and one in light-chain amyloidosis:
· TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. This trial is currently ongoing, and patients continue to be treated to progression and will be evaluated for long-term outcomes.
· TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
· TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)
· TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT
· TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis
In addition to the TOURMALINE program, a large number of investigator initiated studies are evaluating ixazomib for patients globally.
For additional information on the studies please visit To learn more about NINLARO, please visit or call 1-844-N1POINT (1-844-617-6468).
Important Safety Information
WARNINGS AND PRECAUTIONS
· Thrombocytopenia has been reported with NINLARO. During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per standard medical guidelines. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and recovered to baseline by the start of the next cycle.
· Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for severe symptoms.
· Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.
· Peripheral Edema was reported with NINLARO. Monitor for fluid retention. Investigate for underlying causes when appropriate and provide supportive care as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.
· Cutaneous Reactions: Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modification.
· Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in
< 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly during treatment and adjust dosing as needed.
· Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming pregnant, and to use contraception during treatment and for an additional 90 days after the final dose of NINLARO.
The most common adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen, respectively, were diarrhea (42%, 36%), constipation (34%, 25%), thrombocytopenia (78%, 54%; pooled from adverse events and laboratory data), peripheral neuropathy (28%, 21%), nausea (26%, 21%), peripheral edema (25%, 18%), vomiting (22%, 11%), and back pain (21%, 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%).
· Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment.
· Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.
· Lactation: Advise women to discontinue nursing while on NINLARO.
DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers.
Please see the accompanying NINLARO full Prescribing Information.
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 more than 26,000 new cases in the U.S. and 114,000 new cases globally per year.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for 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 its 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,
View source version on businesswire.com:Korea Newswire distributes your news across every media channels through the industry’s largest press release distribution network
TOKYO--( / ) 오야넷 March 07, 2016 -- Toshiba Corporation’s () (TOKYO: 6502) Semiconductor & Storage Products Company today announced that it will showcase 삽입딜도추천 TOKYO--(일본아마존 leading-edge semiconductor and storage technologies and solutions at electronica China 2016. Toshiba will highlight solutions in three areas?Automotive, IoT and Industrial?under the unifying concept of creating a safe, secure and comfortable society. The trade fair for electronic components, 오야넷 오빠미용실 systems and applications will be held at Shanghai New International Expo Centre(SNIEC) from March 15 to 17. 일본아마존 대구남자머리잘하는미용실
서흥남동홀덤카페 2.Venue 오야넷 대구여자성격 : Shanghai 일본아마존 2013세계피겨선수권대회아사다... New 오야넷 International Expo Centre(SNIEC)
딸친구 (1)오야넷 Automotive: 오야넷 성남아이롱다운펌 일본아마존 성남아이롱다운펌
Exhibits will spotlight Toshiba’s line-up of 놀자매 Exhibits어우동티비 Exhibitsfor use in Advanced Driver Assistance System (ADAS) solutions that support a safer driving experience. Leading-edge image 오야넷 김연아쇼트해외반응 processing technologies, including 일본아마존 경대미용실 image 일본아마존 경북대미용실 recognition 일본아마존 컨셉b processors that can execute multiple functions simultaneously, and display controllers that can control head-up displays (HUD) and instrument clusters simultaneously, will be on display. Motor control technologies that support a safer driving experience will also be displayed.
룰루랄라게임 (2)오야넷 대구경대 IoT: 오야넷 챨스헤어 일본아마존 챨스헤어
나나우미나나 Leading-edgeproducts and solutions will underline 일본아마존 세젤르 Toshiba’s contributions 손브라 미션 Leading-edgeIoT, 오야넷 김연아동영상보기 including memory 오야넷 송중기고향 and storage products that meet fast increasing demand for data explosion. Products on 일본아마존 최신헤어 show will include “BiCS FLASH™”, the world’s first 48-layer three dimensional stacked cell structure flash memory, and “BG1 손브라 미션 Leading-edgeSSDs, the world’s smallest. Other IoT solutions on display include “TransferJet™” close proximity wireless communication technology products; “FlashAir™” SDHC memory cards with wireless LAN; and “ApP Lite™” application processors.
(3) 손브라 미션 (3)오야넷 김소리상반신노출 일본아마존 김소리상반신노출
The latest line-up of Toshiba’s discrete power products and analog ICs offer features that contribute to OKCash Theeco-friendly society. High efficiency, high performance discretes will include high 오야넷 스타킹송혜교 power IGBT modules for railroads, power transmission & distribution and inverter systems; 일본아마존 바닐라비키 아즈사나가사와 Thepower products using SiC; and low power loss MOSFETs that lower power consumption in electronic devices. Motor control solutions that cut power consumption and also reduce end-product development time will also be featured.
코니아스포르 Notes:오야넷 카지노바카라게임 일본아마존 카지노바카라게임
 오야넷 블랙잭잘하는법 As 일본아마존 비키니할인 an 소라넷 오야넷 PCIe® interface SSD, as of March 7, 2016. 오야넷 Toshiba 일본아마존 칩걸 survey. 일본아마존 강원랜드칩걸
* BiCs 소라넷 *FlashAir 오야넷 외국인카지노 and ApP Lite 일본아마존 캉캉프릴비키니 are trademarks 오야넷 프릴비키니코디 of 일본아마존 Toshiba Corporation.
* 일본아마존 타짜카지노 NVMe is a trademark of NVM 비아그라 필름 *오야넷 플라워프릴비키니 Inc. 일본아마존 소라카지노
자이그라정 *PCIe is 일본아마존 온라인바둑이 a registered 오야넷 강남카지노바 trademark 오야넷 of PCI-SIG.
Customer 일본아마존 왕뽕프릴비키니 윤활제 Customer오야넷 강친닷컴 일본아마존 강친닷컴
Marketing 먹튀중개소 먹중소) Marketing오야넷 강병규카지노 Communications Section 일본아마존 아이폰홀덤
Information in this document, including 신수동화투치기 Informationprices and 경장동홀덤카페 Informationcontent of services and 오야넷 바카라게임 contact information, is current on the date 토토일보 Informationthe announcement but is 일본아마존 바카라게임방법 subject to change 오야넷 와이어왕뽕비키니 without 일본아마존 수영복원피스 prior notice.
Toshiba Corporation, a Fortune Global 500 company, channels world-class capabilities in advanced electronic 오야넷 poker and electrical product and systems into five strategic business 일본아마존 domains: Energy & Infrastructure, Community Solutions, Healthcare Systems & Services, Electronic Devices & Components, and Lifestyles Products & Services. 토렌트아이 Toshibaby the principles of The Basic Commitment of the Toshiba Group, 일본아마존 폴로원피스 “Committed to People, Committed to the 오이넷 ToshibaToshiba promotes 일본아마존 global operations and is contributing to the realization of a world where generations to come can live better lives.
Founded in Tokyo in 1875, today’s Toshiba is at the 박무비 Foundedof a global network of over 오야넷 580 6974TV Foundedcompanies employing 일본아마존 어깨넓은여자비키니 199,000 people worldwide, 오야넷 복불복 with annual 일본아마존 우리카지노 sales 일본아마존 여자비키니몸매 surpassing 6.6 trillion 리더벳 Founded(US$55 billion).
|전화번호 :||영업시간 :|
|홈페이지 :||위치정보 :|
등록된 댓글이 없습니다.