TGCT can be a lifelong condition with long-term impacts resulting from both the disease and treatments^1-3

TGCT can have a major impact on
QOL and physical function²

Symptoms commonly reported by patients included:

OVER 90%
HAD PAIN⁴*457 out of 497 patients
85% HAD LIMITED
RANGE OF MOTION (ROM)⁴*423 out of 497 patients

*Results from an international, observational, prospective registry of 497 patients initiated in 2022 by TGCT Support, a program of The Life Raft Group.⁴

QOL=quality of life.

Persistent disease may cause cartilage destruction and bone erosion, in addition to functional limitations from the tumor mass, resulting in long‑term pain and joint dysfunction.⁵

In a multicenter, retrospective cohort study including 45 patients with diffuse TGCT who did not have osteoarthritis at baseline⁶:

18% DEVELOPED RADIOLOGICAL SIGNS OF JOINT DEGENERATION⁶

8 out of 45 patients

While surgical resection is considered the standard of care, it is not always curative^2,7

Up to72%Recurrence
ratehas been reported after
resection in diffuse TGCT⁴

There are risks and limitations associated with TGCT surgical resection^3,7

Repeated surgical resections can lead to increased morbidity, including acceleration of secondary osteoarthritis, permanent joint damage, and other lifelong consequences^3,7

Repeated surgeries and multiple recurrences can turn TGCT into a chronic, lifelong condition.^1,2

“Patients with TGCT require long‑term treatment and need therapeutic options that can improve the symptoms of TGCT... with manageable toxicity profiles.”⁸

Gelderblom H, et al. Lancet. 2024.

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References: 1. Stacchiotti S, Durr HR, Schaefer IM, et al. Best clinical management of tenosynovial giant cell tumour (TGCT): a consensus paper from a community of experts. Cancer Treat Rev. 2023;112:102491. 2. Bernthal NM, Spierenburg G, Healey JH, et al. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey: a prospective multicenter study. Orphanet J Rare Dis. 2021;16(1):191. 3. Verspoor FGM, Mastboom MJL, Hannink RG, et al. Long-term efficacy of imatinib mesylate in patients with advanced tenosynovial giant cell tumor. Sci Rep. 2019;9(1):14551. 4. Stern S, McKenzie PF, Bernthal N, et al. Localized and diffuse tenosynovial giant cell tumor: real-world results from a patient observational registry. Future Oncol. 2025;21(12):1501–1510. 5. Tap WD, Gelderblom H, Palmerini E. Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial. Lancet. 2019;394:478-487. 6. Spierenburg G, Staals EL, Palmerini E, et al. Active surveillance of diffuse-type tenosynovial giant cell tumors: a retrospective, multicenter cohort study. Eur J Surg Oncol. 2024;50(2):107953. 7. Lin F, Kwong WJ, Shi S, Pivneva I, Wu EQ, Abraham JA. Surgical treatment patterns, healthcare resource utilization, and economic burden in patients with tenosynovial giant cell tumor who underwent joint surgery in the United States. J Health Econ Outcomes Res. 2022;9(1):68-74. 8. Gelderblom H, Bhadri V, Stacchiotti S, et al. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;403(10445):2709-2719.

IMPORTANT SAFETY
INFORMATION & INDICATION

Indications 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.

Important Safety Information

Warnings and Precautions

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hepatotoxicity:

Cases of serious and fatal liver injury have occurred with the use of another kinase inhibitor that targets CSF1R. Serious and fatal liver injury have not been observed with ROMVIMZA.
Elevated AST and ALT can occur with ROMVIMZA.
Avoid ROMVIMZA in patients with pre‑existing increased serum transaminases; total bilirubin or direct bilirubin (>ULN); or active liver or biliary tract disease, including ALP.
Monitor liver function tests prior to initiation of ROMVIMZA, twice a month for the first two months and once every 3 months for the first year of therapy and as clinically indicated thereafter. Withhold and reduce the dose, or permanently discontinue ROMVIMZA based on the severity of the hepatotoxicity.

Embryo-Fetal Toxicity:

ROMVIMZA may cause fetal harm when administered to pregnant women. Advise pregnant women on the potential risk to the fetus.
Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with ROMVIMZA and for 1 month after the last dose.

Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow FCF):

ROMVIMZA 20 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic reactions (including bronchial asthma) in certain susceptible patients. FD&C Yellow No. 5 (tartrazine) sensitivity is frequently seen in patients who also have aspirin sensitivity.
Advise patients that ROMVIMZA 14 mg and 20 mg capsules contain FD&C Yellow No. 6 (Sunset Yellow FCF), which may cause allergic reactions.

Increased Creatinine without Affecting Renal Function:

Increases in serum creatinine can occur with the use of ROMVIMZA. These increases in serum creatinine may not be associated with changes in renal function. Increases in creatinine reversed upon ROMVIMZA discontinuation. During ROMVIMZA treatment, use alternative measures that are not based on serum creatinine to assess renal function.

Adverse Reactions:

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.

Drug Interactions:

P-glycoprotein (P-gp) substrates: Avoid concomitant use of ROMVIMZA with P-gp substrates. If concomitant use cannot be avoided, take ROMVIMZA at least 4 hours prior to P-gp substrates.
Breast Cancer Resistance Protein (BCRP) substrates: Avoid concomitant use of ROMVIMZA with BCRP substrates.
Organic Cation Transporter 2 (OCT2) substrates: Avoid concomitant use of ROMVIMZA with OCT2 substrates.
Concomitant use of vimseltinib with P-gp substrates, BCRP substrates or OCT2 substrates may increase exposure of these substrates.

Lactation: Advise females not to breastfeed during treatment with ROMVIMZA.

Please click for the full Prescribing Information.

Indications and Usage

IMPORTANT SAFETY
INFORMATION & INDICATION

Indications and Usage

Important Safety Information

Warnings and Precautions

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hepatotoxicity:

Cases of serious and fatal liver injury have occurred with the use of another kinase inhibitor that targets CSF1R. Serious and fatal liver injury have not been observed with ROMVIMZA.
Elevated AST and ALT can occur with ROMVIMZA.
Avoid ROMVIMZA in patients with pre‑existing increased serum transaminases; total bilirubin or direct bilirubin (>ULN); or active liver or biliary tract disease, including ALP.
Monitor liver function tests prior to initiation of ROMVIMZA, twice a month for the first two months and once every 3 months for the first year of therapy and as clinically indicated thereafter. Withhold and reduce the dose, or permanently discontinue ROMVIMZA based on the severity of the hepatotoxicity.

Embryo-Fetal Toxicity:

ROMVIMZA may cause fetal harm when administered to pregnant women. Advise pregnant women on the potential risk to the fetus.
Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with ROMVIMZA and for 1 month after the last dose.

Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow FCF):

ROMVIMZA 20 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic reactions (including bronchial asthma) in certain susceptible patients. FD&C Yellow No. 5 (tartrazine) sensitivity is frequently seen in patients who also have aspirin sensitivity.
Advise patients that ROMVIMZA 14 mg and 20 mg capsules contain FD&C Yellow No. 6 (Sunset Yellow FCF), which may cause allergic reactions.

Increased Creatinine without Affecting Renal Function:

Increases in serum creatinine can occur with the use of ROMVIMZA. These increases in serum creatinine may not be associated with changes in renal function. Increases in creatinine reversed upon ROMVIMZA discontinuation. During ROMVIMZA treatment, use alternative measures that are not based on serum creatinine to assess renal function.

Adverse Reactions:

Drug Interactions:

P-glycoprotein (P-gp) substrates: Avoid concomitant use of ROMVIMZA with P-gp substrates. If concomitant use cannot be avoided, take ROMVIMZA at least 4 hours prior to P-gp substrates.
Breast Cancer Resistance Protein (BCRP) substrates: Avoid concomitant use of ROMVIMZA with BCRP substrates.
Organic Cation Transporter 2 (OCT2) substrates: Avoid concomitant use of ROMVIMZA with OCT2 substrates.
Concomitant use of vimseltinib with P-gp substrates, BCRP substrates or OCT2 substrates may increase exposure of these substrates.

Lactation: Advise females not to breastfeed during treatment with ROMVIMZA.

Please click for the full Prescribing Information.

TGCT can have a .css-18ihmun{--tw-text-opacity:1;color:rgb(255 93 71 / var(--tw-text-opacity, 1));}major impact onQOL and physical function2

While surgical resection is considered the standard of care, it is not always curative2,7

Get information about ROMVIMZA

TGCT can have a major impact on
QOL and physical function²

While surgical resection is considered the standard of care, it is not always curative^2,7