ROMVIMZA is a kinase inhibitor, designed
to potently and selectively inhibit CSF1R^1-3

TGCT is caused by dysregulation of the CSF1 gene leading to overexpression of CSF1^4,5

In TGCT, overexpression of CSF1 leads to the recruitment of tumor‑promoting, inflammatory cells to tumor sites⁶

A tumor cell, CSF1, and inflammatory cells with CSF1R and CSF1 present

CSF1R inhibition with vimseltinib targets CSF1/CSF1R signaling, a driver of TGCT tumor growth^6,7

ROMVIMZA® (vimseltinib) attaching itself to an inflammatory cell where CSF1R and CSF1 are present

Vimseltinib is highly selective for CSF1R with >100-fold selectivity for inhibiting CSF1R vs all other kinases tested^3,7

Vimseltinib was designed to be selective for CSF1R versus the closely related kinases KIT, FLT3, PDGFRA, and PDGFRB, as well as other kinases tested⁷
In vitro, vimseltinib inhibited downstream CSF1R signaling as well as CSF1R‑dependent cell proliferation⁷

CSF1=colony‑stimulating factor 1; CSF1R=colony‑stimulating factor 1 receptor; FLT3=FMS‑like tyrosine kinase 3; KIT=KIT proto‑oncogene receptor tyrosine kinase; MOA=mechanism of action; MOD=mechanism of disease; PDGFRA=platelet‑derived growth factor receptor alpha; PDGFRB=platelet‑derived growth factor receptor beta.

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References: 1. ROMVIMZA [package insert]. Waltham, MA: Deciphera Pharmaceuticals, LLC. 2. Caldwell TM, Ahn YM, Bulfer SL, et al. Discovery of vimseltinib (DCC‑3014), a highly selective CSF1R switch‑control kinase inhibitor, in clinical development for the treatment of tenosynovial giant cell tumor (TGCT). Bioorg Med Chem Lett. 2022;74:128928. 3. Gelderblom H, Razak AA, Taylor MH, et al. CSF1R inhibition in patients with advanced solid tumors or tenosynovial giant cell tumor: a phase 1 study of vimseltinib. Clin Cancer Res. 2024;30:3996-4004. 4. Lin F, Kwong WJ, Shi S, Pivneva I, Wu EQ, Abraham JA. Surgical treatment patterns, healthcare resource utilization, and economic burden in patients with tenosynovial giant cell tumor who underwent joint surgery in the United States. J Health Econ Outcomes Res. 2022;9(1):68–74. 5. Cannarile MA, Weisser M, Jacob W, et al. Colony-stimulating factor 1 receptor (CSF1R) inhibitors in cancer therapy. J Immunother Cancer. 2017;5(1):53. 6. West RB, Rubin BP, Miller MA, et al. A landscape effect in tenosynovial giant-cell tumor from activation of CSF1 expression by a translocation in a minority of tumor cells. Proc Natl Acad Sci USA. 2006;103(3):690-695. 7. Smith BD, Kaufman MD, Wise SC, et al. Vimseltinib: a precision CSF1R therapy for tenosynovial giant cell tumors and diseases promoted by macrophages. Mol Cancer Ther. 2021;20(11):2098–2109.

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.

TGCT is caused by dysregulation of the CSF1 gene leading to overexpression of CSF1.css-5trxlg{font-size:70%;}4,5

CSF1R inhibition with vimseltinib targets CSF1/CSF1R signaling, a driver of TGCT tumor growth6,7

Help your patients get started on ROMVIMZA

TGCT is caused by dysregulation of the CSF1 gene leading to overexpression of CSF1^4,5

CSF1R inhibition with vimseltinib targets CSF1/CSF1R signaling, a driver of TGCT tumor growth^6,7