Ono's ROMVIMZA Approval Shakes Up Tenosynovial Giant Cell Tumors Market, Challenging Daiichi Sankyo's TURALIO Dominance | DelveInsight

On February 14, 2025, Ono Pharmaceuticals secured FDA approval for vimseltinib, a therapy for tenosynovial giant cell tumor (TGCT), which will be marketed as ROMVIMZA. This approval places Ono in direct competition with another Japanese pharmaceutical company, Daiichi Sankyo, in the TGCT market.

LAS VEGAS, March 4, 2025 /PRNewswire/ -- Tenosynovial giant cell tumor, also known as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is primarily treated through surgical resection. For localized TGCT, the typical approach involves direct removal of the tumor nodule. In contrast, diffused-type TGCT (DTGCT) tends to present as larger tumors affecting major joints, making treatment more complex. Management options for DTGCT often include total synovectomy, joint replacement, or, in extremely rare cases, amputation.

Among the 7MM, the United States had the highest prevalence of tenosynovial giant cell tumor, accounting for approximately 45% of total cases. In 2023, localized TGCT in the U.S. was most commonly found in the digits, representing around 75% of cases. Depending on whether the tumor is localized or diffuse, giant cell tumors can also occur in the knee, ankle, hip, and other areas. According to DelveInsight analysts, diffuse TGCT was most frequently observed in the knee, with an estimated 30,000 cases in the US in 2023.

The primary approach to treating TGCT is surgery, often supplemented by alternative options like Radiation Therapy, Radiosynovectomy, and Systemic Therapies, including CSF1 inhibitors and Tyrosine Kinase Inhibitors. TURALIO (pexidartinib, previously known as PLX3397) is a targeted therapy developed by Daiichi Sankyo for adult patients with symptomatic tenosynovial giant cell tumor that leads to significant morbidity or functional limitations and cannot be effectively treated with surgery. 

This orally administered small-molecule tyrosine kinase inhibitor acts on colony-stimulating factor 1 receptor (CSF1R), KIT proto-oncogene receptor tyrosine kinase (KIT), and FMS-like tyrosine kinase 3 (FLT3) with an internal tandem duplication (ITD) mutation. Overexpression of the CSF1R ligand contributes to excessive cell proliferation and accumulation in the synovium.  

The US FDA approved TURALIO in August 2019 for the treatment of TGCT in adults with severe symptoms and limited surgical options. Before this, in October 2015, pexidartinib received Breakthrough Therapy Designation (BTD) from the FDA for TGCT treatment. TURALIO carries a risk of serious and potentially life-threatening liver toxicity and is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program.

Learn more about the FDA-approved TGCT drugs @ Drugs for Tenosynovial Giant Cell Tumors Treatment

Recently, in February 2025, Ono Pharmaceuticals secured FDA approval for vimseltinib for the treatment of tenosynovial giant cell tumor. Marketed under the brand name ROMVIMZA, the drug places Ono in direct competition with fellow Japanese pharmaceutical company Daiichi Sankyo in the TGCT space.  

Like TURALIO, which became the first FDA-approved TGCT treatment in 2019, ROMVIMZA is a colony-stimulating factor 1 receptor (CSF1R) inhibitor. As a kinase inhibitor, it blocks the CSF1 receptor to slow the growth of cells expressing this protein, potentially limiting tumor progression in TGCT.  

Ono Pharmaceuticals acquired ROMVIMZA through its $2.4 billion purchase of Deciphera Pharmaceuticals last year, making the U.S.-based firm a subsidiary. At the time, Ono's CEO, Gyo Sagara, described the acquisition as a strategic effort to expand the company's targeted oncology pipeline, strengthen its presence in the U.S. and European markets, and enhance its kinase drug discovery expertise.  

To compete with TURALIO's early market entry, Ono is positioning ROMVIMZA as a more convenient TGCT treatment. Unlike Daiichi Sankyo's drug, which requires twice-daily dosing, ROMVIMZA is administered only twice a week, with at least 72 hours between doses. Additionally, while TURALIO carries a boxed warning for hepatotoxicity due to the risk of severe liver damage, ROMVIMZA does not have this safety warning.

To know more about TGCT treatment options, visit @ New Treatment for Tenosynovial Giant Cell Tumors

TGCT that is not amenable to improvement from surgery. Several companies, such as SynOx Therapeutics (Emactuzumab), AmMax Bio (AMB-05X), Merck KGaA (pimicotinib), and others, are involved in developing therapies for TGCT.

Discover which therapies are expected to grab major TGCT market share @ Tenosynovial Giant Cell Tumors Market Report

Pimicotinib is an investigational, orally administered small-molecule inhibitor designed to selectively and effectively target the colony-stimulating factor-1 receptor. Developed by Abbisko, it remains under clinical evaluation. In December 2023, Abbisko Therapeutics agreed with Merck, granting Merck exclusive rights to commercialize pimicotinib-based products for all indications in mainland China, Hong Kong, Macau, and Taiwan, with the possibility of expanding to global markets, including the US.  

Pimicotinib has been granted Breakthrough Therapy Designation (BTD) by both the China National Medical Products Administration (NMPA) and the FDA, as well as Priority Medicine (PRIME) designation by the European Medicines Agency (EMA) for the treatment of patients with TGCT who are not candidates for surgery.  

In November 2024, Merck reported that the Phase III MANEUVER trial, conducted by Abbisko Therapeutics, met its primary endpoint. The study showed a significant improvement in the objective response rate (ORR) for patients with tenosynovial giant cell tumor. By week 25, pimicotinib achieved an ORR of 54.0%, compared to 3.2% in the placebo group (p<0.0001).

Emactuzumab is a monoclonal antibody that serves as a potent and selective inhibitor of CSF-1R. By interacting with two key cytokines, CSF-1 and IL-34, the CSF-1 receptor plays a crucial role in regulating macrophages and related cells across various biological processes and organ systems. This makes it a compelling target with wide-ranging therapeutic potential.  

SynOx Therapeutics is currently assessing emactuzumab in the Phase III TANGENT clinical trial. In April 2024, the company secured a $35 million loan facility from Hercules Capital, bolstering its financial position as it advances the trial. Additionally, SynOx successfully completed a $75 million Series B funding round. Earlier, in August 2022, the European Medicines Agency (EMA) granted orphan medicinal product designation to emactuzumab for both localized and diffuse TGCT.

AMB-05X is a powerful monoclonal antibody targeting CSF1R, designed as a therapeutic platform for severe macrophage-driven inflammatory, fibrotic, and neovascular conditions. It has received Fast Track designation from the FDA and PRIME designation from the EMA for TGCT. Currently, it is being evaluated in a Phase II clinical trial to assess its safety, tolerability, efficacy, and pharmacokinetics when administered via intra-articular injection in TGCT patients.

Discover more about drugs for TGCT in development @ Tenosynovial Giant Cell Tumors Clinical Trials

The anticipated launch of these emerging therapies for TGCT are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the TGCT market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

DelveInsight estimates that the market size for TGCT is expected to grow from USD 300 million in 2023, with a significant CAGR by 2034. This growth can be attributed to the approval of new therapies with improved safety and tolerability compared to pexidartinib, which will significantly impact the treatment landscape in the coming years. This will lead to increased adoption of these new therapies, with patients transitioning from off-label treatments to these newer options during the forecast period (2023‒2034).

DelveInsight's latest published market report, titled as Tenosynovial Giant Cell Tumors Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the TGCT country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The TGCT market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Prevalent Cases of TGCT
• Growth Pattern-specific Prevalent Cases of TGCT
• Gender-specific Prevalent Cases of Localized TGCT
• Gender-specific Prevalent Cases of Diffuse TGCT
• Tumor Location-specific of Localized TGCT
• Tumor Location-specific Cases of Diffuse TGCT
• Total Treated Cases of TGCT

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM TGCT market. Highlights include:

• 10-year Forecast
• 7MM Analysis
• Epidemiology-based Market Forecasting
• Historical and Forecasted Market Analysis upto 2034
• Emerging Drug Market Uptake
• Peak Sales Analysis
• Key Cross Competition Analysis
• Industry Expert's Opinion
• Access and Reimbursement

Download this TGCT market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the TGCT market. Also, stay abreast of the mitigating factors to improve your market position in the TGCT therapeutic space.

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