An ongoing phase 2 study of patients
with previous anti-CSF1R therapy¹

An open-label study in adult patients with symptomatic TGCT¹

With previous anti‑CSF1R therapy (n=20)¹

80% (16 out of 20 patients) previously received pexidartinib
- Patients had discontinued pexidartinib due to disease progression (n=5), toxicity (n=2), or other reasons (n=9)
Patients received ROMVIMZA 30 mg twice weekly

Reduction in tumor length per RECIST^1*(n=19)

Response rate by RECIST (%); 26% ORR at week 25; 26% PR; 0% CR; 5 out of 19 (95% CI: 9, 51); 37% best overall response (BOR); 37% PR; 0% CR; 7 out of 19 (95% CI: 16, 62)

Data cutoff was March 1, 2024; 19/20 patients had ≥1 post-baseline imaging assessment as of the data cutoff (efficacy evaluable population).

Reduction in tumor volume per TVS¹(n=19)

Response rate by TVS (%); 26% ORR at week 25; 26% PR; 0% CR; 5 out of 19 (95% CI: 9, 51); 42% best overall response (BOR); 42% PR; 0% CR; 8 out of 19 (95% CI: 20, 67)

Data cutoff was March 1, 2024.

Analysis limitations

This study evaluated the preliminary efficacy of vimseltinib; no statistical hypothesis testing was conducted
Other limitations: potential bias due to lack of blinding and randomization, the lack of a comparator arm, and small numbers of patients

Clinical outcome assessments¹

Clinical outcome assessments at Week 25¹
Mean change from baseline in active ROM (n=13)	14.1%
Mean change from baseline in PROMIS-PF (n=15)	6.2 points
Response rate in BPI-30 worst pain^‡	55% (11/20)

The safety profile was consistent with the MOTION study¹

The median treatment duration was 11.1 months for those with previous anti‑CSF1R therapy, with 65% (13/20) of patients on treatment at data cutoff^1§

*RECIST v1.1.

^†Patients that either reached Week 25 or discontinued treatment or study prior to Week 25 were included.

^‡BPI-30 worst pain responder is defined as a participant who experiences a decrease of at least 30% in the mean BPI-30 worst pain score and does not experience a 30% or greater increase in narcotic analgesic use.

^§Data cutoff was March 1, 2024.

BPI=Brief Pain Inventory; CI=confidence interval; CR=complete response; CSF1R=colony‑stimulating factor 1 receptor; ORR=objective response rate; PR=partial response; PROMIS‑PF=Patient‑Reported Outcomes Measurement Information System Physical Function (TGCT‑specific); RECIST v1.1=Response Evaluation Criteria in Solid Tumors version 1.1; ROM=range of motion; TGCT=tenosynovial giant cell tumor; TVS=tumor volume score.

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Reference: 1. Stacchiotti S, Blay JY, Rutkowski P, et al. Vimseltinib for patients with tenosynovial giant cell tumor: A multicenter, open-label, phase 2 trial.Cancer. 2026;132(17):e70564. doi:10.1002/cncr.70564

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.

An open-label study in adult patients with symptomatic TGCT1

With previous anti‑CSF1R therapy (n=20)1

Clinical outcome assessments1

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An open-label study in adult patients with symptomatic TGCT¹

With previous anti‑CSF1R therapy (n=20)¹

Clinical outcome assessments¹

Help your patients get started on ROMVIMZA