Romvimza (vimseltinib) / Ono Pharmaceutical, Deciphera Pharmaceuticals - LARVOL DELTA

Tenosyovial giant cell tumor (TGCT): From the physiopathology to the emergence of new targeted therapies (PubMed, Bull Cancer) - "This disease, although not lethal, has major functional and psychosocial consequences. Surgery is the main treatment ; CSF1R inhibitors are emerging for unresectable or recurrent disease and are available since March 2026 requiring a rethink of the patient care journey."

Journal • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

A phase I study of the CSF1R inhibitor vimseltinib in combination with the PD-L1 inhibitor avelumab in patients with advanced sarcoma. (PubMed, ESMO Open) - "Vimseltinib plus avelumab was generally safe and well tolerated. This combination had minimal clinical efficacy in our population of heavily pretreated patients with sarcoma."

Journal • P1 data • Oncology • Sarcoma • Solid Tumor

Efficacy, safety, and patient-reported outcomes of vimseltinib in patients with tenosynovial giant cell tumor: Results from the phase 3 MOTION trial. (ASCO 2024) - P3 | "Patients treated with vimseltinib experienced statistically significant and clinically meaningful improvements in ORR by RECIST v1.1 and by TVS, active ROM, physical function, stiffness, health status, and pain vs pbo. Vimseltinib is an effective, well-tolerated CSF1R-targeted therapy that demonstrates significant clinical benefit and improves functional health and QoL in pts with symptomatic TGCT not amenable to surgery."

Clinical • P3 data • Patient reported outcomes • Giant Cell Tumor of Bone • Hepatology • Liver Failure • Oncology • Pain • Tenosynovial Giant Cell Tumor • CSF1R

Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. (PubMed, Lancet) - P3 | "Vimseltinib produced a significant objective response rate and clinically meaningful functional and symptomatic improvement in patients with TGCT, providing an effective treatment option for these patients."

Journal • P3 data • Giant Cell Tumor of Bone • Hepatology • Liver Failure • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor

CSF1R Inhibition in Patients With Advanced Solid Tumors or Tenosynovial Giant Cell Tumor: A Phase 1 Study of Vimseltinib. (PubMed, Clin Cancer Res) - P1/2 | "Vimseltinib demonstrated long-term tolerability, manageable safety, dose-dependent exposure, and robust antitumor activity in patients with TGCT whose disease is not amenable to surgery."

Journal • Metastases • P1 data • Giant Cell Tumor of Bone • Hepatology • Liver Failure • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor • CSF1R

Updated efficacy and safety of vimseltinib in patients (pts) with tenosynovial giant cell tumor (TGCT): One-year follow-up from the MOTION phase III trial (ESMO 2024) - P3 | "In this first report of long-term results (≥1 year) from MOTION, vimseltinib continued to be well tolerated and provided long-term antitumor responses in pts with TGCT not amenable to surgery."

Clinical • Late-breaking abstract • P3 data • Giant Cell Tumor of Bone • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor

Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Deciphera Pharmaceuticals, LLC | Trial completion date: Dec 2027 ➔ Dec 2026

Trial completion date

Vimseltinib for patients with tenosynovial giant cell tumor: A multicenter, open-label, phase 2 trial. (PubMed, Cancer) - P1/2 | "Vimseltinib had a manageable safety profile, demonstrated durable antitumor activity, and provided functional and symptomatic improvements in patients with TGCT, offering an effective treatment option regardless of previous treatment with anti-CSF1/CSF1R agents."

Journal • P2 data • Giant Cell Tumor of Bone • Hepatology • Liver Failure • Oncology • Pain • Tenosynovial Giant Cell Tumor • CSF1R

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (14 August 2026) approved vimseltinib (romvimza) to treat adult patients with tenosynovial giant cell tumour (TGCT) when it impacts movement or where surgery is not an option. (GOV.UK) - "Vimseltinib is a capsule that should be swallowed whole with water and with or without food, twice a week."

MHRA approval • Tenosynovial Giant Cell Tumor

Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Deciphera Pharmaceuticals, LLC

New P1 trial

Romvimza: Launch in Japan for tenosynovial giant cell tumor in FY2029 or later (Ono Pharmaceuticals) - Q1 FY2026 Results

Launch Japan • Oncology • Tenosynovial Giant Cell Tumor

Combination therapy in sarcomas and the challenges of heterogeneity. (PubMed, Chin Clin Oncol) - No abstract available

Heterogeneity • Journal • Oncology • Sarcoma • Solid Tumor

Romvimza: Launch in Japan for tenosynovial giant cell tumor in FY2028 or later (Ono Pharmaceuticals) - R&D Day

Launch Japan • Oncology • Tenosynovial Giant Cell Tumor

DCC-3014-01-001: Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor (clinicaltrials.gov) - P1/2 | N=120 | Active, not recruiting | Sponsor: Deciphera Pharmaceuticals, LLC | Trial primary completion date: Jul 2026 ➔ Aug 2028

Trial primary completion date • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

Vimseltinib vs. pexidartinib: An indirect comparison of response rate in the treatment of tenosynovial giant cell tumor. (ASCO 2026) - "Vimseltinib appears to be as effective as pexidartinib in producing similar response rates as documented by radiological response by RECIST criteria. However, given that vimseltinib appears to have a better toxicity profile than pexidartinib, it may offer a better treatment option to patients with TGCT as both agents have been shown to have similar response rates."

Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor • CSF1

Effects of colony stimulating-factor 1 receptor inhibitors in an in vitro cell culture model using synovial fluids from tenosynovial giant cell tumor patients (EULAR 2026) - "The remaining cells were cultured in plates with or without exposure to a CSF1R inhibitor (kinase inhibitor (Imatinib, Pexidartinib, Vimseltinib, Pimicotinib) or neutralizing antibody (Emactuzumab)). Analyses on more samples are required to confirm these results and identify predictive factors of response to inhibitors. Image(s), graphic(s), or table(s)"

Preclinical • Giant Cell Tumor of Bone • Immunology • Inflammatory Arthritis • Oncology • Psoriatic Arthritis • Seronegative Spondyloarthropathies • Tenosynovial Giant Cell Tumor • CD14 • CD163 • CEACAM8 • MERTK • NCAM1 • PTPRC • THY1

Romvimza: Launch in Japan for tenosynovial giant cell tumor in FY2029 or later (Ono Pharmaceuticals) - FY2025 Results

Launch Japan • Oncology • Tenosynovial Giant Cell Tumor

IDENTIFYING TENOSYNOVIAL GIANT CELL TUMOR (TGCT) IN SECONDARY DATA: METHODOLOGICAL CHALLENGES, EMERGING OPPORTUNITIES, AND FUTURE DIRECTIONS (ISPOR 2026) - "Inclusion criteria required ≥1 inpatient/emergency department or outpatient claim, and/or received TGCT-targeted systemic therapy (e.g., pexidartinib, vimseltinib). Terminological inconsistencies and coding limitations complicate TGCT identification in secondary datasets. Standardizing diagnostic criteria and coding practices across geographies is crucial for improving global TGCT surveillance, particularly as targeted systemic therapies gain prominence. Descriptive analyses of the algorithm indicate that the identification strategy has face validity and clinical plausibility; integration with complementary data sources, such as pathology, imaging, and natural language processing of electronic health records will be essential for accuracy."

Giant Cell Tumor of Bone • Oncology • Orthopedics • Tenosynovial Giant Cell Tumor

Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Deciphera Pharmaceuticals, LLC | Not yet recruiting ➔ Recruiting

Enrollment open

Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Deciphera Pharmaceuticals, LLC

New P1 trial

Clinicopathologic Characteristics of Pexidartinib- Treated Tenosynovial Giant Cell Tumor (USCAP 2026) - "Design: We performed a retrospective search of all TGCT at a single institution from 2019-2025 and reviewed cases with treatment by CSF1R inhibitor (Pexidartinib or Vimseltinib). Pexidartinib-treated TGCT can show unique radiologic and histologic changes compared to conventional untreated TGCT. Histologic changes range from reduction in giant/mononuclear cells to complete absence of lesional tissues. Recognition on the histologic spectrum and treatment effects of CSF1R inhibition in TGCT is critical for its accurate diagnosis."

Clinical • Fibrosis • Giant Cell Tumor of Bone • Immunology • Oncology • Tenosynovial Giant Cell Tumor

MOTION: Study of Vimseltinib for Tenosynovial Giant Cell Tumor (clinicaltrials.gov) - P3 | N=123 | Active, not recruiting | Sponsor: Deciphera Pharmaceuticals, LLC | Trial completion date: Jul 2026 ➔ Jul 2028

Trial completion date • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

Pooled safety of vimseltinib in patients (pts) with tenosynovial giant cell tumor (TGCT) who received no prior colony-stimulating factor 1 receptor (CSF1R) inhibitor therapy (Sarcoma-RC 2026) - P1/2, P3 | "Legal entity responsible for the study Deciphera Pharmaceuticals, LLC. Funding Deciphera Pharmaceuticals, LLC."

Giant Cell Tumor of Bone • Hepatology • Liver Failure • Oncology • Tenosynovial Giant Cell Tumor

Vimseltinib in non-resecable tenosynovial giant cell tumor (PubMed, Bull Cancer) - No abstract available

Journal • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

DCC-3014-01-001: Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor (clinicaltrials.gov) - P1/2 | N=120 | Active, not recruiting | Sponsor: Deciphera Pharmaceuticals LLC | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2022 ➔ Dec 2023

Enrollment closed • Trial primary completion date • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor