A new TGCT treatment
THAT TARGETS CSF-1 SIGNALING1
NOW FDA APPROVED
What is PIMJETMI® (pimicotinib)?
PIMJETMI 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.1
PIMJETMI significantly reduced tumor size for more than half of people with TGCT in the 25-week clinical study (~6 months)1
PIMJETMI was studied in MANUEVER, a phase 3 trial including 94 adults with symptomatic TGCT when surgery may make the symptoms worse or cause severe problems. Participants were randomly assigned to receive PIMJETMI (n=63) or placebo (n=31). Patients were grouped by region: China versus Europe and North America.1,5
The main goal of the study was to determine the percent of people whose tumors decreased by 30% in length, also called the overall response rate (ORR), as measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.1,6
people taking PIMJETMI1
people taking placebo1
- The ORR was 65% (95% CI: 45-81) for people taking PIMJETMI in China (n=31) and 47% (95% CI: 29-65) for people taking PIMJETMI in Europe and North America (n=32)1
- When the imaging scans were read by the study doctors (rather than blinded independent outside experts), tumors shrank for 35% of people taking PIMJETMI and 0% of people taking placebo1
The only once-daily treatment for TGCT1
Glass of water
Healthcare provider
Capsule with a slash through it
To help manage side effects, your doctor may tell you to stop taking PIMJETMI temporarily or reduce your dose to 1 pill a day (instead of 2). Talk to your doctor before changing your dose of PIMJETMI.¹
If you forget to take a dose of PIMJETMI and remember within 12 hours, take the missed dose. If more than 12 hours have passed, skip the dose you missed and stay on your regular schedule.1
Most people were able to start and stay on the full dose of PIMJETMI in the 6-month study1,5
of people did not complete the study5,a
a94% of people took PIMJETMI for the full 6 months. One person stopped taking PIMJETMI due to a side effect (tiredness).1,5
of people had their dose lowered to help manage side effects5,b
bSide effects that caused more than 1% of people to take a lower dose of PIMJETMI included rash, a change in blood tests, tiredness, and headache.1
What are some of the side effects of PIMJETMI?
The most common side effects of PIMJETMI (seen in more than 20% of people) were itching, rash, swelling of the face, swelling around the eyes, fatigue, nausea, headache, swelling of the hands and feet, changes in certain blood tests, and other side effects.1
MANEUVER pivotal trial (6 months)a
Most common clinical adverse events (≥10% and >5% compared with placebo)1
PIMJETMI
(n=63)
Placebo
(n=31)
(swelling of the face)
Periorbital edemae
(swelling around the eyes)
(swelling of the hands or feet)
(high blood pressure)
aData cutoff: September 23, 2024.5
bThe severity of adverse reactions was assessed using Common Terminology Criteria for Adverse Events v5.0.1
cIncludes multiple related terms.1
dIncluded one patient with a medical history of hypertension and one patient with abnormal blood pressure at baseline.7
- The majority of side effects did not need to be managed by reducing the dose of, or discontinuing, PIMJETMI7,8
- To manage side effects, your doctor may tell you to pause PIMJETMI temporarily or reduce your dose to 1 pill a day (instead of 2)1
- Most people who started PIMJETMI stayed on it—over the course of 6 months, 1 out of 63 people taking PIMJETMI discontinued treatment due to a side effect (fatigue that didn’t get better with rest)1
- PIMJETMI may cause a change in certain blood tests, such as increased liver enzymes. Although liver injury did not occur during the 6-month study of PIMJETMI, your doctor will do blood tests to check for liver problems before starting treatment and regularly throughout treatment1
Most common laboratory adverse events (≥10% and >5% compared with placebo)1
PIMJETMI
(n=63)
Placebo
(n=31)
(muscle enzyme)
(cell enzyme)
(liver enzyme)
(pancreatic enzyme)
increased
(pancreatic enzyme)
(liver enzyme)
(kidney marker)
(infection-fighting cells)
(infection-fighting cells)
(immune cells)
eLaboratory abnormalities were all asymptomatic and responded well to brief dose interruptions.7
fIncludes grade 4 events.1
ALT=alanine aminotransferase; AST=aspartate aminotransferase; CPK=creatine phosphokinase; LDH=low-density lipoprotein.
No cases of drug-induced liver damage were reported by patients taking PIMJETMI.1,5
PIMJETMI can cause serious side effects, including liver problems. Increased liver enzymes in your blood are common with PIMJETMI. Your healthcare provider will do blood tests to check for liver problems before starting treatment with PIMJETMI and during treatment.1
No REMS programg is required with PIMJETMI1
gRisk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the US Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about PIMJETMI?
PIMJETMI can cause serious side effects, including liver problems.
Increased liver enzymes in your blood are common with PIMJETMI.
Your healthcare provider will do blood tests to check for liver problems:
- Before starting treatment with PIMJETMI,
- Every month for the first 3 months,
- Then every 3 months for the rest of the first year after starting treatment and as needed thereafter during treatment with PIMJETMI.
If you develop liver problems during treatment with PIMJETMI, 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 PIMJETMI including yellowing of your skin or the white part of your eyes, dark urine, lack or loss of appetite, pain or tenderness on the upper right side of your stomach-area (abdomen), feeling overly tired, nausea, vomiting, fever, rash and itching.
Before taking PIMJETMI, 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. PIMJETMI 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 PIMJETMI.
- Use effective birth control (contraception) during treatment and for 2 weeks after your last dose of PIMJETMI.
- Tell your healthcare provider right away if you become pregnant or you think you may be pregnant during treatment with PIMJETMI.
-
Males with female partners who are able to become pregnant:
- Use effective birth control (contraception) during treatment and for 2 weeks after your last dose of PIMJETMI.
- Tell your healthcare provider right away if your female partner becomes pregnant or thinks she may be pregnant during treatment with PIMJETMI.
-
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if PIMJETMI passes into your breast milk. Do not breastfeed during treatment with PIMJETMI and for 2 weeks after your last dose of PIMJETMI.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking PIMJETMI with certain other medicines may affect the way that PIMJETMI or the other medicine works and may increase your risk of side effects.
What are the possible side effects of PIMJETMI?
PIMJETMI can cause serious side effects.
The most common side effects of PIMJETMI include:
- itching
- rash
- swelling of your face
- swelling around your eyes
- tiredness
- nausea
- headache
- swelling of your hands and feet
- change in certain blood tests
PIMJETMI 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 PIMJETMI. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Approved Use
PIMJETMI (pimicotinib) 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 PIMJETMI is safe and effective in children.
Please click for full Prescribing Information and Medication Guide.
REFERENCES
1. PIMJETMI. Prescribing information. EMD Serono, Inc. 2. Spierenburg G, van der Heijden L, van Langevelde K, et al. Tenosynovial giant cell tumors (TGCT): molecular biology, drug targets and non-surgical pharmacological approaches. Expert Opin Ther Targets. 2022;26(4):333-345. doi:10.1080/14728222.2022.2067040. 3. Tap WD, Healey JH. Role of colony-stimulating factor 1 in the neoplastic process of tenosynovial giant cell tumor. Tumour Biol. 2022;44(1):239-248. doi:10.3233/TUB-220005. 4. Riedel RF, Eward W, Verini C, et al. Improving resources and support for patients with tenosynovial giant cell tumor. CancerCare. Published April 26, 2021. Accessed July 2, 2026. https://media.cancercare.org/publications/original/431-2021_TGCT.pdf. 5. Xu H, Niu X, Ravi V, et al. Pimicotinib versus placebo for tenosynovial giant cell tumour (MANEUVER): an international, randomized, placebo-controlled, phase 3 trial. Lancet. 2026;407(10533):1072-1083. doi:10.1016/S0140-6736(25)02602-9. 6. Villaruz LC, Socinski MA. The clinical viewpoint: definitions, limitations of RECIST, practical considerations of measurement. Clin Cancer Res. 2013;19(10):2629-2636. doi:10.1158/1078-0432.CCR-12-2935. 7. Supplement to: Xu H, Niu X, Ravi V, et al. Pimicotinib versus placebo for tenosynovial giant cell tumour (MANEUVER): an international, randomized, placebo-controlled, phase 3 trial. Lancet. 2026;407(10533):1072-1083. doi:10.1016/S0140-6736(25)02602-9. 8. Data on file: EMD Serono, Inc.