ROMVIMZA wasProven to significantly reduce tumors^1,2

40% of patients taking ROMVIMZA experienced a robust reduction in tumor length of 30% or more^1‑3

ORR BY RECIST AT 6 MONTHS^1,3*

40% ROMVIMZA™ (vimseltinib). 33 out of 83 patients (95% CI: 29,51). 0% placebo. 0 out of 40 patients (95% CI: 0,9). P<0.0001. 35% PR; 5% CR.

BEST PERCENTAGE CHANGE IN TARGET LESIONS IN
PATIENTS RECEIVING ROMVIMZA³

Best percentage change from baseline in targeted lesions (%) graph

The dotted line at -30% represents the threshold for partial response. Each bar represents an individual patient's best response (for patients who had an assessment at the end of part 1). Data cutoff: August 22, 2023.

*RECIST v1.1

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.

Analysis limitations for waterfall plot

Waterfall plot shows best change from baseline by RECIST for individual patients and is intended to be descriptive only

2 out of 3 patients taking ROMVIMZA experienced a robust reduction in tumor volume of 50% or more^1‑3

ORR BY TUMOR VOLUME SCORE (TVS) AT 6 MONTHS^1,3

67% ROMVIMZA™ (vimseltinib). 56 out of 83 patients (95% CI: 56,77). 0% placebo. 0 out of 40 patients (95% CI: 0,9). P<0.0001. 63% PR; 5% CR†.

BEST PERCENTAGE CHANGE IN TARGET LESIONS IN
PATIENTS RECEIVING ROMVIMZA^4‡

Best percentage change from baseline in target lesions (%) graph

The dotted line at -50% represents the threshold for partial response. Each bar represents an individual patient's best response (for patients who had an assessment at the end of part 1). Data cutoff: August 22, 2023.

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

^‡13 patients taking ROMVIMZA had no change in TVS.⁴

CI=confidence interval; CR=complete response; ORR=objective response rate; PR=partial response.

Analysis limitations for waterfall plot

Waterfall plot shows best change from baseline by TVS for individual patients and is intended to be descriptive only
TVS expresses tumor volume as a percentage of the estimated volume of the maximally distended involved synovial cavity or tendon sheath

Tumor responses were maintained in long‑term follow‑up for over a year⁵

DURATION OF RESPONSE BY RECIST^5§

Tumor responses were maintained in long‑term follow‑up for over a year⁵

12 of the 33 responses lasted 12 months or longer⁵
The median duration of response for the 33 responders was not reached (range, 2.5+ to 19.4+ months^∥)⁵

^§RECIST v1.1

^∥ “+” indicates that the patient's response was ongoing at last assessment as of the data cutoff date (February 22, 2024).⁵

DOR=duration of response; RECIST v1.1=Response Evaluation Criteria in Solid Tumors version 1.1.

Help your patients get started on ROMVIMZA

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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) (suppl):1-124. 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):2709-2719. 4. Data on file. Deciphera Pharmaceuticals, Inc; 2025. 5. Gelderblom H, Bhadri VA, Stacchiotti S, et al. Updated efficacy and safety of vimseltinib in patients with tenosynovial giant cell tumor (TGCT): One-year follow-up from the MOTION phase III trial. 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.

40% of patients taking ROMVIMZA experienced a robust reduction in tumor length of 30% or more1‑3

BEST PERCENTAGE CHANGE IN TARGET LESIONS IN.css-1hahsgh{display:none;}@media (min-width: 1024px){.css-1hahsgh{display:inline;}} PATIENTS RECEIVING ROMVIMZA3

Analysis limitations for waterfall plot

2 out of 3 patients taking ROMVIMZA experienced a robust reduction in tumor volume of 50% or more1‑3

BEST PERCENTAGE CHANGE IN TARGET LESIONS IN PATIENTS RECEIVING ROMVIMZA4‡

Analysis limitations for waterfall plot

Tumor responses were maintained in long‑term follow‑up for over a year5

Tumor responses were maintained in long‑term follow‑up for over a year5

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40% of patients taking ROMVIMZA experienced a robust reduction in tumor length of 30% or more^1‑3

BEST PERCENTAGE CHANGE IN TARGET LESIONS IN
PATIENTS RECEIVING ROMVIMZA³

2 out of 3 patients taking ROMVIMZA experienced a robust reduction in tumor volume of 50% or more^1‑3

BEST PERCENTAGE CHANGE IN TARGET LESIONS IN
PATIENTS RECEIVING ROMVIMZA^4‡

Tumor responses were maintained in long‑term follow‑up for over a year⁵

Tumor responses were maintained in long‑term follow‑up for over a year⁵

Help your patients get started on ROMVIMZA