How ROMVIMZA can help

ROMVIMZA was studied in one of the largest placebo‑controlled clinical trials for TGCT

In MOTION, the clinical trial for ROMVIMZA, tumor response was measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at 25 weeks (approximately 6 months).

The trial compared ROMVIMZA to placebo (a pill with no active medication)
The trial included 123 participants with symptomatic TGCT for whom surgery could have made the symptoms worse or caused severe problems
The trial included participants who had previous surgeries and participants without previous surgeries

Tumor locations included	ROMVIMZA n=83	Placebo n=40
Knee	56	27
Hip	11	1
Ankle	9	6
Foot, wrist, hand, shoulder, elbow, and temporomandibular joint*	7	6

*A joint that connects the lower jaw to the skull.

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Who can take ROMVIMZA?

You can take ROMVIMZA if:

You have symptomatic TGCT and surgery may make the symptoms worse or cause severe problems
You've had multiple surgeries or no prior surgery
You've used other prescription or over‑the‑counter medications for TGCT or its symptoms

ROMVIMZA showed robust tumor reduction when compared to placebo

Objective response rates at 6 months^†

Tumor response was measured in the 123 participants (some given placebo) in 2 ways:

Tumor Length:

40%of people taking ROMVIMZA experienced a tumor response (vs 0% taking placebo)

33 out of 83 people

35% had partial tumor shrinkage by at least 30%

5% had their tumors disappear completely

Assessed using RECIST v1.1

Tumor Volume:

67%of people taking ROMVIMZA experienced a tumor response (vs 0% taking placebo)

56 out of 83 people

63% had partial tumor shrinkage by at least 50%
5% had their tumors disappear completely

Assessed using Tumor Volume Score (TVS)

^†Study endpoints were measured at 25 weeks, which is approximately 6 months.

Range of motion (ROM) improved 18.4% in patients taking ROMVIMZA vs 3.8% in patients taking placebo

5x greater improvement in ROM was demonstrated in patients taking ROMVIMZA vs placebo at 6 months

Examples of range of motion

Using the knee as an example, the average range of motion achieved with ROMVIMZA is 83.6% which is equal to 112 degrees vs 68.3% which is equal to 92 degrees with placebo

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ROMVIMZA goes beyond tumor reduction

At approximately 6 months

Physical function

Patients taking ROMVIMZA reported significant improvement in physical function compared to those taking placebo
(4.6 vs 1.3 point improvement in PROMIS-PF at week 25)

More patients taking ROMVIMZA reported clinically meaningful improvement in physical function than placebo
(43% vs 25%)

Based on the results of PROMIS-PF, a questionnaire in which clinical trial participants were asked to grade their ability to perform their normal daily activities.

Pain

Significantly more patients taking ROMVIMZA had a response in worst pain compared to those taking placebo
(48% vs 23%)

Response was at least a 30% improvement in their worst pain without increasing their use of pain medications by 30% or more.

Even those taking ROMVIMZA who did not have a tumor response experienced improvements in range of motion, pain, and/or physical function^‡

^‡Limitations: This was an exploratory analysis, meaning it was not specifically designed to find differences. Therefore, these results may be due to chance and should be interpreted carefully. Individual results may vary from the clinical trial experience.

Ask about ROMVIMZA

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Important Safety Information

What is the most important information I should know about ROMVIMZA?

ROMVIMZA can cause serious side effects, including liver problems. Increased liver enzymes in your blood are common with ROMVIMZA.

Your healthcare provider will do blood tests to check for liver problems:

before starting treatment with ROMVIMZA,
2 times each month for the first 2 months of treatment,
then 1 time every 3 months for the first year of treatment and as clinically indicated thereafter.

If you develop liver problems during treatment with ROMVIMZA, your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop treatment depending on how severe your liver problems are.

Tell your healthcare provider right away if you develop any signs or symptoms of liver problems during treatment with ROMVIMZA including yellowing of your skin or the white part of your eyes, dark urine, lack or loss of appetite, right upper stomach‑area (abdomen) pain or tenderness, feeling overly tired, nausea, vomiting, fever, rash, and itching.

Before taking ROMVIMZA, tell your healthcare provider about all of your medical conditions, including if you:

have or had liver problems.
are pregnant or plan to become pregnant. ROMVIMZA can harm your unborn baby.

Females who are able to become pregnant:

Your healthcare provider will do a pregnancy test before you start treatment with ROMVIMZA.
Use effective birth control (contraception) during treatment with ROMVIMZA and for 1 month after the last dose. Talk to your healthcare provider about birth control methods that may be right for you.
Tell your healthcare provider right away if you become pregnant or you think you may be pregnant during treatment with ROMVIMZA.

Males with female partners who are able to become pregnant:

Use effective birth control (contraception) during treatment with ROMVIMZA and for 1 month after the last dose.
Tell your healthcare provider right away if your female partner becomes pregnant or thinks she may be pregnant during treatment with ROMVIMZA.

are breastfeeding or plan to breastfeed. It is not known if ROMVIMZA passes into your breast milk. Do not breastfeed during treatment with ROMVIMZA and for 1 month after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking ROMVIMZA with certain other medicines may affect the way that ROMVIMZA or the other medicine works and may increase your risk of side effects.

What are the possible side effects of ROMVIMZA?

ROMVIMZA can cause serious side effects.

Allergic reactions to FD&C Yellow No. 5 and FD&C Yellow No. 6. ROMVIMZA 20 mg capsules contain the inactive ingredients FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6 (Sunset Yellow FCF). ROMVIMZA 14 mg capsules contain the inactive ingredient FD&C Yellow No. 6 (Sunset Yellow FCF). FD&C Yellow No. 5 (tartrazine) can cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin. FD&C Yellow No. 6 (Sunset Yellow FCF) can also cause allergic reactions. Tell your healthcare provider if you get hives, rash, or trouble breathing during treatment with ROMVIMZA.

The most common side effects of ROMVIMZA include:

swelling around your eyes
tiredness
rash
increased cholesterol levels in your blood

swelling of your hands or feet
swelling of your face
decreased white blood cells
itchy skin

ROMVIMZA may cause fertility problems, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of ROMVIMZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is ROMVIMZA?

ROMVIMZA is a prescription medicine used to treat adults with symptomatic tenosynovial giant cell tumor (TGCT) when surgery may make the symptoms worse or cause severe problems.

It is not known if ROMVIMZA is safe and effective in children.

Please click for the full Prescribing Information, including Medication Guide.