Business Wire

MA-DECIPHERA

Share
European Medicines Agency Accepts Deciphera’s Marketing Authorization Application for Vimseltinib for Treatment of Patients with Tenosynovial Giant Cell Tumor (TGCT)

Ono Pharmaceutical, Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for vimseltinib, a colony stimulating factor 1 receptor (CSF1R), for the treatment of patients with tenosynovial giant cell tumor (TGCT), which is under development by Deciphera Pharmaceuticals, Inc. (“Deciphera”), a wholly-owned subsidiary of Ono. The review of the MAA begins under the EMA’s centralized review process for all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. Vimseltinib was granted Orphan Drug Designation for the treatment of TGCT by the EMA in December 2019.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240717971793/en/

“Building upon positive results from the MOTION pivotal Phase 3 study, we are excited to initiate the regulatory review process in the EU and we are one step closer in our mission to bring vimseltinib to TGCT patients in need of an effective and well-tolerated treatment,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals.

The submission is supported by the data from the pivotal Phase 3 MOTION study, evaluating the efficacy and safety of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed), compared to placebo. In the study, vimseltinib demonstrated a statistically significant and clinically meaningful objective response rate (ORR) at Week 25 in the intent-to-treat (ITT) population, as assessed by Blinded Independent Radiologic Review (BIRR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), versus placebo (40% in vimseltinib arm vs 0% in placebo arm, p <0.0001). Additionally, vimseltinib demonstrated statistically significant and clinically meaningful improvements versus placebo in all key secondary endpoints. The safety profile of vimseltinib is manageable and safety data from MOTION are consistent with data previously disclosed in the Phase 1/2 clinical trial of vimseltinib*. Data from the MOTION study was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

*: Gelberblom, et at. 2024 ASCO Annual Meeting

About the MOTION Study
The MOTION study is a two-part, randomized, double-blind, placebo-controlled Phase 3 clinical study to assess the efficacy and safety of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed). The primary endpoint of the study is an objective response rate (ORR) at Week 25 in the intent-to-treat (ITT) population, as assessed by Blinded Independent Radiologic Review (BIRR) per using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), versus placebo. The secondary endpoint includes ORR per tumor volume score (TVS), active range of motion (ROM), physical function, stiffness, quality of life, and pain, all assessed at Week 25. This study consists of two Parts. In Part 1, patients were randomized to receive either vimseltinib or placebo for 24 weeks. In Part 2, patients randomized to placebo in Part 1 have the option to receive vimseltinib, and all patients receive vimseltinib for a long-term period in an open-label setting.

About Tenosynovial Giant Cell Tumor (TGCT)
TGCT is a rare disease caused by a translocation in colony-stimulating factor 1 (CSF1) gene resulting in overexpression of CSF1 and recruitment of colony-stimulating factor 1 receptor (CSF1R)-positive inflammatory cells into the lesion. TGCT is a rare, non-malignant tumor that develops inside or near joints. TGCT is caused by dysregulation of the CSF1 gene leading to overproduction of CSF1. TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS), a diffuse-type of TGCT. Although benign, these tumors can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in diffuse-type TGCT. If untreated or if the tumor continually recurs, damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability. For a subset of patients who are not amenable to surgery, systemic treatment options are limited and a new therapeutic option for TGCT is needed.

About Vimseltinib
Vimseltinib is an investigational, oral switch-control tyrosine kinase inhibitor specifically designed to selectively and potently inhibit CSF1R. Vimseltinib has been developed using Deciphera’s proprietary switch-control kinase inhibitor platform.

About Deciphera Pharmaceuticals Inc.
(As of June 11, 2024, Deciphera is now a member of ONO Pharma.)
Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera’s switch-control inhibitor approved for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is approved in many countries including the European Union and the United States. For more information, visit www.deciphera.com and follow us on LinkedIn and Twitter (@Deciphera).

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240717971793/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars19.2.2025 03:57:00 CET | Press release

Celltrion gains simultaneous regulatory approval of two monoclonal antibody biosimilars across three treatments – Eydenzelt® (aflibercept), Stoboclo® and Osenvelt® (denosumab) in the EU marketEuropean Commission approval based on totality of evidence including extensive comparative analytical, pharmacokinetic and clinical dataThe company expands its biosimilar portfolio to 11 in 2025 as planned, further strengthening its commitment to a portfolio of 22 drugs by 2030 Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt® (CT-P42, aflibercept), a biosimilar to Eylea® to treat multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV); and Stoboclo® and Osenvelt® (CT-P41, denosumab), biosimilars ref

IFF Reports Fourth Quarter and Full Year 2024 Results18.2.2025 22:49:00 CET | Press release

International Flavors & Fragrances Inc. (NYSE: IFF) reported financial results for the fourth quarter and full year ended December 31, 2024. Management Commentary "IFF delivered a solid performance in 2024, reflecting the hard work and dedication of our global team,” said CEO Erik Fyrwald. "Their commitment to serving our customers with industry-leading innovation drove strong top and bottom-line financial results. I’m pleased with the significant progress we’ve made over the past year yet believe that we still have more work to do to realize IFF's full potential. In 2025, we'll strategically increase our investment in R&D, commercial, capacity and technology as we aim to continue to strengthen IFF. Recognizing ongoing macroeconomic uncertainties, we remain confident in our strategy and our ability to navigate challenges as we continue to create long-term value for all shareholders." Full year 2024 Consolidated Financial Results Reported net sales for the full year were $11.48 billion,

SES Market Update in Context of Moody’s Ratings Press Release18.2.2025 18:10:00 CET | Press release

SES S.A. has taken note of Moody’s Ratings Press Release today with regards to SES and is providing a market update ahead of its Full Year 2024 financial results announcement on 26 February 2025. SES expects Full Year 2024 Results(1) to be better-than-expected with Revenue at the top end of the financial outlook range (€1,940-2,000 million)(2) and Adjusted EBITDA above the outlook range (€950-1,000 million)(2). The proposed acquisition of Intelsat is on track to close during H2 2025. SES expects to reconfirm all financial targets for the combined company (pre-IRIS2) published in the transaction announcement in April 2024, including low- to mid-single digit average annual growth in Revenue for 2024-2028E, mid-single digit average annual growth in Adjusted EBITDA for 2024-2028E, and strong Free Cash Flow generation. SES remains committed to maintaining Investment Grade metrics. SES management looks forward to announcing its Full Year 2024 Results and discussing these, as well as its view

Planview Acquires Sciforma, Expanding Global Leadership in Portfolio Management Solutions18.2.2025 18:00:00 CET | Press release

Combined offerings support organizations at every Project Portfolio Management maturity level Planview®, the leading platform for Strategic Portfolio Management (SPM) and Digital Product Development (DPD), today announced it has completed its acquisition of Sciforma, a prominent provider of Project Portfolio Management (PPM) and Product Development solutions. This strategic acquisition further solidifies Planview's position as the undisputed leader in enterprise portfolio management, bringing market-leading solutions to organizations at every PPM maturity level. "By acquiring Sciforma, we're strengthening our commitment to portfolio management practitioners worldwide," said Razat Gaurav, CEO of Planview. "Together, we're building the world's largest community of portfolio and product development professionals, delivering enterprise solutions that address their most critical challenges. No one in the market is better equipped to guide organizations through every stage of their portfolio

Armis Named a Leader in 2025 Gartner® Magic Quadrant™ for CPS Protection Platforms18.2.2025 17:30:00 CET | Press release

Armis supports global enterprises’ vast and varied needs to effectively secure critical CPS environments Armis, the cyber exposure management & security company, today announced that it has been named a Leader in the 2025 Gartner Magic Quadrant for CPS Protection Platforms. Cyber-physical system environments connect the physical and digital worlds, supporting sectors including infrastructure, transportation, healthcare and smart manufacturing. Their growing role increases risk due to complex IT, OT, IoT, and IIoT integrations that need robust security. We believe the Gartner Magic Quadrant for CPS Protection Platforms highlights the importance of protecting these systems. “Attacks on cyber-physical systems can disrupt operations and endanger lives, making their security our core mission, driven by innovation, expertise and customer collaboration,” said Yevgeny Dibrov, CEO and Co-Founder of Armis. “We believe being named a Leader in this report is a testament to the support that we prov

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye