Beyond tumor response,ROMVIMZA delivered significant improvement
in range of motion (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 with ROMVIMZA^1,2

Patients taking ROMVIMZA had a mean ROM of 63.0% at the start of the study and experienced an improvement to 83.6% at 6 months^1,2
Patients taking placebo had a mean ROM of 62.9% at the start of the study and experienced an improvement to 68.3% at 6 months^1,2

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

Using the knee as an example, a total ROM of 83.6% falls within the goal range after a total knee arthroplasty and the range required for typical daily activities including^2-4:

Tying
shoes

Getting in and
out of a chair

Walking up or
down stairs

Walking on
level ground

How ROM was measured and defined^2,4,5

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.

ROMVIMZA significantly improved
certain TGCT symptoms^1,5

Patients on ROMVIMZA showed

Clinically meaningful and statistically significant
improvement in function^1,2,5

Physical function (PROMIS-PF)^1,2,5

Improvements for some patients were seen at first assessment (week 5)⁵

Change from baseline at week 25 in PROMIS‑PF was a prespecified key secondary endpoint in the MOTION study^1,2,5

PROMIS‑PF measures a patient's ability to do a range of daily activities
15‑item questionnaire assessed tumor location‑specific (upper vs lower extremity) physical function
Data for PROMIS‑PF is largely based on lower limb extremity assessment due to tumor location. Higher scores of PROMIS‑PF indicate better physical functioning

*MCID responder: ≥3 point increase from baseline in PROMIS‑PF score at week 25.^2,5

CI=confidence interval; LS=least squares; MCID=minimum clinically important difference; PROMIS‑PF=Patient‑Reported Outcomes Measurement Information System Physical Function (TGCT‑specific); TGCT=tenosynovial giant cell tumor.

ROMVIMZA reduced pain in nearly half of patients^1,2

BPI worst pain response rate at week 25 was a prespecified key secondary endpoint in the MOTION study^1,2,5

Patients were asked to rate their worst pain in the last 24 hours on a scale of 0 (no pain) to 10 (pain as bad as you can imagine)
BPI responder: experienced at least a 30% decrease in mean BPI worst pain and did not experience a 30% or greater increase in narcotic analgesic use at week 25

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.

BPI worst pain response rate at week 25 was a prespecified key secondary endpoint in the MOTION study^1,2,5

Patients were asked to rate their worst pain in the last 24 hours on a scale of 0 (no pain) to 10 (pain as bad as you can imagine)
BPI responder: experienced at least a 30% decrease in mean BPI worst pain and did not experience a 30% or greater increase in narcotic analgesic use at week 25

BPI=Brief Pain Inventory.

"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, Inc. 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. 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. 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 Posture. 2000;12:143-155. 5. 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.

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.

ROMVIMZA significantly improved certain TGCT symptoms1,5

ROMVIMZA reduced pain in nearly half of patients1,2

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ROMVIMZA significantly improved
certain TGCT symptoms^1,5

ROMVIMZA reduced pain in nearly half of patients^1,2

Help your patients get started on ROMVIMZA