Pooled analysis of an ongoing phase 2
study with up to 3 years of follow‑up^1-3

An open-label study in adult patients with symptomatic TGCT^2,3

Without previous anti‑CSF1R therapy (n=46)²

Previous therapy with imatinib or nilotinib was allowed
Patients received ROMVIMZA 30 mg twice weekly

With previous anti‑CSF1R therapy (n=20)³

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

CSF1R=colony-stimulating factor 1 receptor; TGCT=tenosynovial giant cell tumor.

Reduction in tumor length per RECIST¹*

Combined patient population (n=64)

Response rate by RECIST (%). 34% ORR at 25 weeks. 34% PR; 0% CR. 22 out of 64 (95% CI: 23, 47). 56% best overall response (BOR). 55% PR; 2% CR. 36 out of 64 (95% CI: 43, 69).

*RECIST v1.1

^†Percentages may not add up to BOR due to rounding.

CI=confidence interval; CR=complete response; ORR=objective response rate; PR=partial response; RECIST v1.1=Response Evaluation Criteria in Solid Tumors version 1.1.

Reduction in tumor length per RECIST¹*

Analysis limitations

This study evaluated the preliminary efficacy of vimseltinib; no statistical hypothesis testing was conducted
These results represent pooled data from two patient cohorts and should be considered descriptive only
Other limitations: potential bias due to lack of blinding and randomization, the lack of a comparator arm, and small numbers of patients

Reduction in tumor volume per TVS¹

Combined patient population (n=64)

Response rate by TVS (%). 44% ORR at 25 weeks. 44% PR; 0% CR. 28 out of 64 (95% CI: 31, 57). 56% best overall response (BOR). 56% PR; 0% CR. 36 out of 64 (95% CI: 43, 69).

CI=confidence interval; CR=complete response; ORR=objective response rate; PR=partial response; TVS=tumor volume score.

Reduction in tumor volume per TVS¹

Analysis limitations

This study evaluated the preliminary efficacy of vimseltinib; no statistical hypothesis testing was conducted
These results represent pooled data from two patient cohorts and should be considered descriptive only
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 6 months	Combined patient population
Mean change from baseline in active ROM (n=46)	18%
Mean change from baseline in PROMIS-PF (n=50)	4.6 points
Response rate in BPI worst pain^‡ (n=66)	51.5% (34/66)

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

The safety profile was consistent with the MOTION study^2,3

The median treatment duration was 22.2 months for patients without previous anti‑CSF1R therapy and 11.1 months for those with previous anti‑CSF1R therapy, with some patients on treatment for up to 3 years^2,3§

^§Data cutoff was March 1, 2024.

BPI=Brief Pain Inventory; CI=confidence interval; CSF1R=colony‑stimulating factor 1 receptor; PROMIS‑PF=Patient‑Reported Outcomes Measurement Information System Physical Function (TGCT‑specific); ROM=range of motion.

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References: 1. Data on file. Deciphera Pharmaceuticals, Inc; 2025. 2. Serrano C, Blay JY, Rutkowski P, et al. Safety and efficacy with vimseltinib in patients with tenosynovial giant cell tumor who received no prior anti-colony-stimulating factor 1 therapy: ongoing phase 2 study. Poster presented at the European Society for Medical Oncology (ESMO) Congress 2024, Sept 13-17, Barcelona, Spain. 3. D’Amato G, Wagner AJ, Ganjoo KN, et al. Safety, efficacy, and patient-reported outcomes with vimseltinib in patients with tenosynovial giant cell tumor who received prior anti-colony stimulating factor 1 therapy: ongoing phase 2 study. Poster presented at the European Society for Medical Oncology (ESMO) Congress 2024, Sept 13-17, Barcelona, Spain.

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 TGCT2,3

Without previous anti‑CSF1R therapy (n=46)2

With previous anti‑CSF1R therapy (n=20)3

Reduction in tumor length per RECIST1*

Reduction in tumor length per RECIST1*

Reduction in tumor volume per TVS1

Reduction in tumor volume per TVS1

Clinical outcome assessments1

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An open-label study in adult patients with symptomatic TGCT^2,3

Without previous anti‑CSF1R therapy (n=46)²

With previous anti‑CSF1R therapy (n=20)³

Reduction in tumor length per RECIST¹*

Reduction in tumor length per RECIST¹*

Reduction in tumor volume per TVS¹

Reduction in tumor volume per TVS¹

Clinical outcome assessments¹

Help your patients get started on ROMVIMZA