Beyond tumor response,ROMVIMZA delivered significant improvement
in ROM vs placebo^1,2

Almost5XGreater
improvementin active ROM vs placebo at 6 months^1,2

ROM improved 18.4% with ROMVIMZA vs 3.8% with placebo
(95% CI: 4.0, 25.3; P=0.0077)^1,2

Average total ROM achieved at 6 months^1,2

ROMVIMZA

From 63.0% at baseline to 83.6%

Placebo

From 62.9% at baseline to 68.3%

Tumor locations included in the ROM analysis included the knee (67%), ankle (12%), hip (10%), other (5%), foot (3.3%), and wrist (2.4%).¹

How ROM was measured and defined^2-4

ROM was assessed by goniometry and expressed as mean percentage change from baseline relative to a reference standard for the affected joint
Total ROM is the total possible movement for a specific joint, eg, total ROM of a knee is 135°

CI=confidence interval; ROM=range of motion.

ROM (USING THE KNEE AS AN EXAMPLE)^1,2,4,5

Average ROM achieved with ROMVIMZA® (vimseltinib); 83.6% equals 112 degrees (vs 68.3% for placebo equals 92 degrees); Full flexion equals 135 degrees; With ROMVIMZA® equals 112 degrees; The goal of total knee arthroplasty equals between 100 and 110 degrees; With placebo equals 92 degrees; Getting in and out of a chair equals 90 degrees; Walking up or down stairs equals 80 degrees; Tying shoelaces equals 78 degrees; Walking on level ground equals 65 degrees; Full extension equals 0 degrees

CI=confidence interval; ROM=range of motion; TGCT=tenosynovial giant cell tumor.

Patients on ROMVIMZA experienced

rapid (as early as Week 5) and sustained (through 6 months) improvements in physical function and BPI-worst pain^1,6

Improved physical function at 6 months:
4.6 points with ROMVIMZA vs 1.3 points with placebo (95% CI: 1.4, 5.2; P=0.0007)^1,2

Physical function
(PROMIS-PF)^1-3,6

Limitations

These results reflect observed mean values and are provided as supportive context to the primary analysis
In an open-label extension, there is a potential for enrichment of the long-term data for the PROs in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out

BPI worst pain response rate^1,2

Patients with clinically meaningful reduction at 6 months

48% ROMVIMZA® (vimseltinib); 40 out of 83 patients; 23% placebo; 9 out of 40 patients

P=0.0056

*Clinically meaningful threshold: ≥3 point increase from baseline in PROMIS-PF score at Week 25.^2,3

BPI=Brief Pain Inventory; LS=least squares; PROMIS-PF=Patient-Reported Outcomes Measurement Information System Physical Function (TGCT-specific); PROs=patient-reported outcomes.

“Symptomatic benefit was not limited to patients who had objective responses per RECIST; patients receiving ROMVIMZA who had stable disease also had a meaningful improvement in active range of motion and patient-reported outcomes (PRO) measures.”²

Gelderblom H, et al. Lancet. 2024.

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References: 1. ROMVIMZA [package insert]. Waltham, MA: Deciphera Pharmaceuticals, LLC. 2. 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. 3. 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)(suppl):1-124. 4. Rowe PJ, Myles CM, Walker C, et al. Knee joint kinematics in gait and other functional activities measured using flexible electrogoniometry: how much knee motion is sufficient for normal daily life? Gait and Posture. 2000;12:143-155. 5. Hyodo K, Masuda T, Aizawa J, et al. Hip, knee, and ankle kinematics during activities of daily living: a cross-sectional study. Braz J Phys Ther. 2017;21(3):159-166. 6. Bhadri V, Gelderblom H, Stacchiotti S, et al. Long-term clinical outcome assessments in patients with tenosynovial giant cell tumor treated with vimseltinib: 1-year results from the MOTION phase 3 trial. Poster presented at ASCO Annual Meeting, May 3–June 3, 2025, Chicago, IL, USA.

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.

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Help your patients get started on ROMVIMZA