Brand Name
Romvimza
Generic Name
Vimseltinib
View Brand Information FDA approval date: February 14, 2025
Form: Capsule
What is Romvimza (Vimseltinib)?
ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
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Brand Information
ROMVIMZA (Vimseltinib)
1INDICATIONS AND USAGE
ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
2DOSAGE FORMS AND STRENGTHS
14 mg capsule
Orange cap, white body size 4 capsule imprinted with “DCV14” in black ink.
20 mg capsule
Yellow cap, white body size 2 capsule imprinted with “DCV20” in black ink.
30 mg capsule
Light blue cap, white body size 1 capsule imprinted with “DCV30” in black ink.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hepatotoxicity [
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in the Warnings and Precautions reflects exposure to ROMVIMZA in 83 patients with TGCT enrolled in the double-blind portion and in 35 patients with TGCT in the open-label portion who crossed over to ROMVIMZA in MOTION, and in 135 patients with TGCT or solid tumors in other clinical trials.
The safety of ROMVIMZA was evaluated in 83 adult patients with TGCT in MOTION [
Serious adverse reactions occurred in 2.4% of patients who received ROMVIMZA. Serious adverse reactions in ≥1% included subcutaneous abscess (1.2%) and cellulitis (1.2%).
Permanent discontinuation due to an adverse reaction occurred in 4.8% of patients who received ROMVIMZA. Adverse reactions leading to permanent discontinuation in one patient each included periorbital edema, neuropathy, rash, and hypertension.
Dose reductions due to an adverse reaction or laboratory abnormality occurred in 39% of patients who received ROMVIMZA. Adverse reactions leading to dose reductions in ≥2% of patients receiving ROMVIMZA were rash, periorbital edema, peripheral edema, fatigue, pruritus, face edema, increased CPK, neuropathy, and hypertension.
Dose interruptions due to an adverse reaction or laboratory abnormality occurred in 40% of patients who received ROMVIMZA. Adverse reactions leading to interruptions in ≥2% of patients included rash, fatigue, peripheral edema, increased CPK, periorbital edema, face edema, pruritus, neuropathy, and hypertension.
The most common (≥20%) adverse reactions, including laboratory abnormalities that occurred in patients receiving ROMVIMZA were increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT.
Other clinically significant adverse reactions occurring in <10% of patients treated with ROMVIMZA include blurred vision (6%).
Additional clinically significant laboratory abnormality:
5DESCRIPTION
Vimseltinib is a kinase inhibitor. The chemical name of vimseltinib dihydrate is 3-methyl-5-[6-methyl-5-[2-(1-methylpyrazol-4-yl)pyridin-4-yl]oxypyridin-2-yl]-2-(propan-2-ylamino)pyrimidin-4-one, dihydrate.
Vimseltinib is a white to off-white crystalline solid. Vimseltinib is a weak base, very slightly soluble in water. The molecular formula for vimseltinib dihydrate is C
ROMVIMZA (vimseltinib) capsules are supplied as printed hard gelatin capsules containing 14 mg, 20 mg, or 30 mg of vimseltinib (equivalent to 15.18 mg, 21.68 mg, or 32.52 mg of vimseltinib dihydrate, respectively). The capsule contains the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shell contains Brilliant Blue FCF (30 mg strength), erythrosine (30 mg strength), gelatin, Sunset Yellow FCF (14 mg and 20 mg strengths), tartrazine (20 mg), and titanium dioxide.
6CLINICAL STUDIES
The efficacy of ROMVIMZA was evaluated in MOTION (NCT05059262), a phase 3, double-blind, multicenter, randomized (2:1), placebo-controlled study in patients with TGCT for whom surgical resection may cause worsening functional limitation or severe morbidity. Eligible patients had a confirmed diagnosis of TGCT with measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) with at least one lesion having a minimum size of 2 cm. Patients were randomized to placebo or ROMVIMZA 30 mg twice weekly for 24 weeks. Randomization was stratified by tumor location (lower limb versus all other) and region (United States [US] versus non-US). At Week 25, patients who completed the double-blind, randomized part of the trial were eligible to advance to an ongoing, open-label extension study in which all patients received ROMVIMZA.
The major efficacy outcome measure was overall response rate (ORR) as assessed by blinded independent radiological review (IRR) per RECIST v1.1 at Week 25. Additional efficacy outcomes measured at Week 25 included ORR as assessed using tumor volume score (TVS), mean change from baseline in active range of motion of the affected joint at Week 25 measured by goniometry assessments, change from baseline in the Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) 15-item score (upper and lower extremity items), and response of at least a 30% improvement in the mean Brief Pain Inventory (BPI) Worst Pain numeric rating scale (NRS) score without a 30% or greater increase in narcotic analgesic use.
A total of 123 patients were randomized: 83 to ROMVIMZA and 40 to placebo during the double-blind period of the study. The median age was 44 years (range 20 to 78 years); 59% of patients were female; 65% were White, 4% were Asian, 3% were Black or African American, and 28% were not reported or unknown; 69% were not Hispanic or Latino, 3% were Hispanic or Latino, and 28% were not reported or unknown; 74% of patients had prior surgery; 69% of patients had diffuse TGCT; and 23% of patients were previously treated with systemic therapy. Disease locations were knee (67%), ankle (12%), hip (10%), other (5%), foot (3.3%), and wrist (2.4%).
A statistically significant improvement in ORR was demonstrated in patients randomized to ROMVIMZA compared with placebo. Efficacy results in MOTION are summarized in
ORR by TVS was 67% (95% CI: 56, 77) in patients randomized to ROMVIMZA and 0% in patients randomized to placebo; p-value <0.0001.
Individual patient results of change from baseline in active ROM at Week 25 (ROMVIMZA N = 73; placebo N=33) are shown in
Figure 1: Change from Baseline in Active Range of Motion at Week 25 for MOTION
* Percent normal reference range for the affected joint.
+ Response by RECIST v1.1.
7HOW SUPPLIED/STORAGE AND HANDLING
Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Store capsules in their original blister packs until ready to be taken. Do not store ROMVIMZA in another container.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA approved patient labeling (Medication Guide).