Takeda Receives Positive CHMP Opinion for Conditional Approval of NINLAROTM (ixazomib), the First Oral Proteasome Inhibitor, for Use in Patients with Multiple Myeloma
Takeda Pharmaceutical Company Limited (TSE: 4502) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the conditional approval of NINLAROTM (ixazomib) capsules in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. If the European Commission ratifies the CHMP’s opinion and authorization is granted, NINLARO will be the first and only oral proteasome inhibitor approved for use across the European Economic Area, which includes the 28 member states of the European Union as well as Norway, Liechtenstein and Iceland.
“This is great news and a very positive development for myeloma patients in Europe,” said Eric Low, Chief Executive, Myeloma UK, and Board Member, Myeloma Patients Europe. “The improvement in progression free survival in this difficult-to-treat stage of myeloma is significant. In addition to ixazomib’s efficacy in this relapsed and/or refractory group of patients, its manageable safety profile and oral administration makes ixazomib a very welcome new treatment option for this serious and complex cancer. It is important that attention is now turned in earnest to the Health Technology Assessment bodies to ensure their approval of ixazomib.”
Data from the pivotal Phase 3 trial TOURMALINE-MM1 demonstrate that the addition of NINLARO to lenalidomide and dexamethasone provides a significant improvement in progression-free survival when compared to placebo plus lenalidomide and dexamethasone in this patient population. Patients continue to be treated to progression in the trial, with additional evaluations planned for long-term outcomes such as overall survival.
“The heterogeneity of multiple myeloma means that it is very important for patients and physicians to have access to a variety of treatment options, and many physicians are now looking forward to the possibility of adding NINLARO to our treatment armamentarium,” said Philippe Moreau, MD, Head of the Hematology Department at the University Hospital of Nantes, France. “The clinical data strongly support the use of NINLARO in relapsed and/or refractory patients, while also delivering the advantages of an all-oral triplet regimen. In the TOURMALINE-MM1 trial, the NINLARO regimen showed a significant improvement in progression-free survival of 35 percent when compared to the placebo regimen.”
“Today’s positive CHMP opinion for the conditional approval of NINLARO is an important first step to bringing this treatment to a relapsed and/or refractory patient population where there is a significant unmet need,” said Christophe Bianchi, M.D., President, Takeda Oncology. “Currently approved proteasome inhibitors are only available through twice-weekly injections and infusions, which can place additional logistical burdens on patients and their caregivers, who already are dealing with a difficult disease. We hope that the efficacy, convenience and manageable safety profile of this innovative treatment may allow for extended duration of treatment, which has the potential to improve patient outcomes. Thank you to the patients and investigators for their participation in the TOURMALINE-MM1 trial to further our understanding of NINLARO’s benefits.”
For a conditional approval, Takeda is required to provide post-approval updates on safety and efficacy analyses for TOURMALINE-MM1 and some other already ongoing studies to demonstrate the treatment's long-term effects.
NINLARO received its first approval from the U.S. Food and Drug Administration in November 2015 following priority review. In the U.S., it is indicated for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Currently licensed for use in the U.S., Canada, Israel and Venezuela, NINLARO is also under review for approval by a number of regulatory authorities around the world. The CHMP’s positive opinion for the conditional approval of NINLARO will now be reviewed by the European Commission.
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.
NINLAROTM (ixazomib) is an oral proteasome inhibitor, which is being studied in multiple myeloma and systemic light-chain (AL) amyloidosis. It was the first oral proteasome inhibitor to enter Phase 3 clinical trials and to receive approval in the countries listed above.
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, 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
- 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, Takeda supports a number of investigator initiated studies evaluating the use of ixazomib in various combinations in oncology settings for patients globally.
NINLARO TM (ixazomib): Global Important Safety Information
SPECIAL WARNINGS AND PRECAUTIONS
Thrombocytopenia has been reported with NINLARO (28% vs. 14% in the NINLARO and placebo regimens, respectively) with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle. It did not result in an increase in hemorrhagic events or platelet transfusions. Monitor platelet counts at least monthly during treatment with NINLARO and consider more frequent monitoring during the first three cycles. Manage with dose modifications and platelet transfusions as per standard medical guidelines.
Gastrointestinal toxicities have been reported in the NINLARO and placebo regimens respectively, such as diarrhea (42% vs. 36%), constipation (34% vs. 25%), nausea (26% vs. 21%), and vomiting (22% vs. 11%), occasionally requiring use of antiemetic and anti-diarrheal medications, and supportive care.
Peripheral neuropathy was reported with NINLARO (28% vs. 21% in the NINLARO and placebo regimens, respectively). 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%). Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.
Peripheral edema was reported with NINLARO (25% vs. 18% in the NINLARO and placebo regimens, respectively). Evaluate patients for underlying causes and provide supportive care, as necessary. Adjust the dose of dexamethasone per its prescribing information or the dose of NINLARO for severe symptoms.
Cutaneous reactions occurred in 19% of patients in the NINLARO regimen compared to 11% of patients in the placebo regimen. The most common type of rash reported in both regimens was maculo-papular and macular rash. Manage rash with supportive care, dose modification or discontinuation.
Hepatotoxicity, drug-induced liver injury, hepatocellular injury, hepatic steatosis, and hepatitis cholestatic have been uncommonly reported with NINLARO. Monitor hepatic enzymes regularly and adjust dose for Grade 3 or 4 symptoms.
Pregnancy- NINLARO can cause fetal harm. Advise male and females patients of reproductive potential to use contraceptive measures during treatment and for an additional 90 days after the final dose of NINLARO. Women of childbearing potential should avoid becoming pregnant while taking NINLARO due to potential hazard to the fetus. Women using hormonal contraceptives should use an additional barrier method of contraception.
Lactation- It is not known whether NINLARO or its metabolites are excreted in human milk. There could be potential adverse events in nursing infants and therefore breastfeeding should be discontinued.
SPECIAL PATIENT POPULATIONS
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 (ESRD) requiring dialysis. NINLARO is not dialyzable and, therefore, can be administered without regard to the timing of dialysis.
Co-administration of strong CYP3A inducers with NINLARO is not recommended.
The most frequently reported adverse reactions (≥ 20%) in the NINLARO regimen, and greater than in the placebo regimen, were diarrhea (42% vs. 36%), constipation (34% vs. 25%), thrombocytopenia (28% vs. 14%), peripheral neuropathy (28% vs. 21%), nausea (26% vs. 21%), peripheral edema (25% vs. 18%), vomiting (22% vs. 11%), and back pain (21% vs. 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). For each adverse reaction, one or more of the three drugs was discontinued in ≤ 1% of patients in the NINLARO regimen.
For US Prescribing Information:
For Canada Product Monograph: http://www.takedacanada.com/ninlaropm
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.
Takeda Pharmaceutical Company Limited
Kate Burd, +41 79 514 9533
Media outside Japan/EU
Amy Atwood, +1 617 444 2147
Tsuyoshi Tada, +81 (0) 3 3278 2417
Om Business Wire
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
Scientist.com Collaborates With UKCRC Tissue Directory and Coordination Centre to Ensure Quality of Human Biosample Acquisition Globally18.10.2017 11:01 | Pressemelding
Scientist.com, the world’s leading marketplace for outsourced scientific services, today announced that it is entering into a collaboration with the UKCRC Tissue Directory and Coordination Centre (UKCRC TDCC) to support the work of biobanks throughout the United Kingdom. The partnership will enable drug R&D to move forward more quickly by making large collections of prescreened human biological samples available for scientific research. Through the new COMPLI™ feature, Scientist.com provides a simple, efficient and effective way of increasing the visibility and accessibility of biobanks’ human biological samples collections, which support new medical research. COMPLI™ introduces a common, comprehensive process and supply agreement supporting access to human biosamples. The goal is to enable biobanks to more easily connect with researchers in the pharmaceutical and biotech indust
Assurant to Acquire the Warranty Group in Transaction Valued at $2.5 Billion18.10.2017 10:30 | Pressemelding
Assurant, Inc. (NYSE:AIZ), a premier global provider of risk management solutions, and The Warranty Group, a leading global provider of protection plans and related programs, and a portfolio company of TPG Capital, today announced that they have entered into a definitive agreement to combine operations, with Assurant shareholders retaining majority ownership of the combined company. The transaction is valued at approximately $2.5 billion and is expected to close in the first half of 2018, subject to shareholder and regulatory approvals, and other customary closing conditions. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171018005269/en/ The transaction will significantly advance Assurant’s strategy in the global lifestyle market with an attractive product and client portfolio, diversified growth profile and a deeper glob
Boost the Connectivity and Memory on Your Phone with FuZion18.10.2017 09:47 | Pressemelding
IDEMIA (formerly known as OT-Morpho), the global leader in trusted identities for an increasingly digital world, today announces the solution for a problem everyone encounters: the choice between connectivity and memory for one’s smartphone. With FuZion, a fantastic device combining the technologies of a SIM card with a microSD card, users will never have to make this choice again. Nowadays, most people need to have two SIM cards, one for personal use and the other for a professional one. At the same time, people require their smartphone to have a lot of memory. That is why today, more and more smartphones have a dual SIM tray, with a hybrid slot for two SIM cards or for one SIM card and a microSD card. With FuZion, no compromises: users can simultaneously have two SIM cards and a microSD card in their phone. FuZion is available for more than 50 smartphone models from
Capgemini Gives Technology a Human Touch, with a New Brand Identity Designed by BrandPie.18.10.2017 08:30 | Pressemelding
Capgemini, one of the world’s leading global technology and consulting firms, yesterday launched its new brand identity, designed by strategic brand consultancy BrandPie. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171018005101/en/ Capgemini's new brand identity, designed by BrandPie BrandPie worked in close collaboration with Capgemini’s leadership team over 15 months to create a dynamic digital-first brand identity and wordmark, inspired by the handwriting of Serge Kampf, Capgemini’s founder. Meanwhile, its iconic spade emblem has been redrawn to reflect the world the business is now in. Coinciding with the Group’s 50th anniversary, this is the first overhaul of Capgemini’s brand identity since 2004, and has been crafted to ensure that it remains ahead of its peers in its
GSMA and AIC Encourage Greater Engagement among RCEP Countries to Enable a Truly Pan-Asian Digital Economy18.10.2017 07:00 | Pressemelding
The GSMA and the Asia Internet Coalition (AIC) today urged the participating countries of the Regional Comprehensive Economic Partnership (RCEP) for greater commitment and engagement. As representatives of leading companies that operate in the region and promote the digital economy, the GSMA and AIC believe that the RCEP can play a critical role in enabling positive policy development in the digital economy and reducing or removing barriers and restrictions that suppress digital trade and investments in the Asia Pacific region. “The RCEP will play an increasingly important role in the region’s digital future, as it involves all of the largest Asian economies, including both ASEAN and non-ASEAN nations,” said Alasdair Grant, head of Asia Pacific for the GSMA. “This is even more critical in light of the stalled talks on the Trans-Pacific Partnership, as well as the growing need for innov
Utimaco Launches PaymentServer 3.00.0 To Help Payment Industry Reach PCI Compliance18.10.2017 06:11 | Pressemelding
As the Payment Card Industry (PCI) continues to heat up, Utimaco is providing enterprises in the banking and financial services sector with the opportunity to achieve PCI compliance through its latest launch, PaymentServer 3.00.0. The new PaymentServer is a PCI Standards Security Council accredited PCI PIN Transaction Security Hardware Security Module Version 2 (PCI PTS HSM V2) solution that comes with a complete offering, including the HSM, a Software Development Kit, and additional services such as integration support, certification assistance and tiered maintenance. All of this allows Utimaco partners to focus on business innovation with the assurance that their work remains or regains PCI compliance. Using Utimaco’s flexible software development kit, companies can reach full PCI compliance for a solution or environment based on the standard product offering from PaymentServer or vi
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom