Onco360 Has Been Selected as a National Specialty Pharmacy Partner for ROMVIMZA™ (vimseltinib)
LOUISVILLE, Ky., June 23, 2025 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent specialty pharmacy, has been selected as a specialty pharmacy partner by Deciphera Pharmaceuticals, LLC for ROMVIMZA™ (vimseltinib), which has been approved by the U.S. Food and Drug Administration for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.1 This indication was approved based on the Phase III MOTION study of ROMVIMZA in patients with tenosynovial giant cell tumor (TGCT).2
“Onco360 is grateful for the opportunity to partner with the team at Deciphera and become a specialty pharmacy provider for ROMVIMZA,” said Benito Fernandez, Chief Commercial Officer. “This addition reflects our ongoing commitment to addressing unmet medical needs while enhancing the quality of life for those affected by rare musculoskeletal disorders.”
Vimseltinib is a kinase inhibitor that inhibits colony-stimulating factor 1 receptor (CSF1R). In vitro, vimseltinib inhibited CSF1R autophosphorylation, signaling induced by CSF1 ligand binding, and proliferation of cells expressing CSF1R.1
The U.S. FDA approved ROMVIMZA based on the results of the MOTION trial, a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy. Patients (n=123) were randomized 2:1 to receive either ROMVIMZA 30 mg BIW (n=83) or matching placebo (n=40). The study met its primary endpoint demonstrating statistically significant and clinically meaningful improvement versus placebo in objective response rate at week 25 by RECIST v1.1 per IRR. The ORR by RECIST v1.1 at Week 25 was 40% (95% CI: 29%, 51%) for ROMVIMZA versus 0% (95% CI: 0%, 9%) for placebo. In addition to meeting the primary endpoint, the study also achieved statistically significant and clinically meaningful improvements versus placebo in all six key secondary endpoints assessed at Week 25 including ORR per tumor volume score (TVS) by IRR, active range of motion (ROM), physical function, stiffness, health status, and pain.2
Vimseltinib was well tolerated in the MOTION trial. The most common adverse reactions and laboratory abnormalities occurring in ≥ 20% of patients were increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT.1
Please see the full Prescribing Information for ROMVIMZA™.
About Onco360 Oncology Pharmacy:
Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.
Media Contact: Benito Fernandez, Chief Commercial Officer
Benito.Fernandez@Onco360.com
516-640-1332
References:
1Romvimza (Vimseltinib) [Package Insert]. Waltham, MA. Deciphera Pharmaceuticals. 2025.
2Gelderblom, HansLoong, Herbert et al. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet, Volume 403, Issue 10445, 2709 – 2719.
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