FDA approves Merck KGaA's Pimjetmi for symptomatic tenosynovial giant cell tumour

Merck KGaA's oral CSF1R inhibitor Pimjetmi has received FDA approval for adults with symptomatic tenosynovial giant cell tumour when surgery could cause substantial functional impairment, supported by a 56% response rate in the Phase III MANEUVER trial.

The US Food and Drug Administration approved Pimjetmi (pimicotinib) on 10 November 2026 for adults with symptomatic tenosynovial giant cell tumour where surgical resection may cause worsening functional limitation or severe morbidity, providing a new oral treatment option from EMD Serono, the US healthcare business of Merck KGaA.

In the Phase III MANEUVER trial, 56% of patients receiving pimicotinib achieved an objective response at Week 25 compared with 3.2% receiving placebo, alongside reported improvements in pain, joint mobility and physical function; the recommended dose is 50 mg orally once daily, with label warnings covering hepatotoxicity and embryo-fetal toxicity.

Field	Content
Article Type	Approvals
Company	Merck KGaA
US Healthcare Business	EMD Serono
Product	Pimjetmi
Active Ingredient	Pimicotinib
Regulatory Authority	US Food and Drug Administration
Approval Date	10 November 2026
Approval Type	FDA marketing approval
Regulatory Status	Approved in the United States for the specified symptomatic TGCT population
Therapeutic Area	Oncology and rare tumours
Disease	Tenosynovial giant cell tumour
Disease Abbreviation	TGCT
Approved Population	Adults with symptomatic TGCT for whom surgical resection may cause worsening functional limitation or severe morbidity
Treatment Setting	Symptomatic disease where surgery presents substantial functional or morbidity concerns
Drug Class	Oral kinase inhibitor
Molecular Target	Colony-stimulating factor 1 receptor
Target Abbreviation	CSF1R
Administration Route	Oral
Recommended Dose	50 mg once daily
Supporting Clinical Trial	MANEUVER
Clinical Trial Phase	Phase III
Primary Efficacy Measure	Objective response rate at Week 25
Pimicotinib Response Rate	56%
Placebo Response Rate	3.2%
Additional Clinical Outcomes	Reported improvements in pain, joint mobility and physical function
Key Safety Warning One	Hepatotoxicity
Key Safety Warning Two	Embryo-fetal toxicity
Previous Regulatory Designations	Earlier Fast Track and breakthrough therapy designations
What Happened	The FDA granted marketing approval to Pimjetmi for a defined adult population with symptomatic TGCT.
Why It Matters	The approval provides an oral treatment option for patients whose tumour location or surgical risks may make resection difficult.
Clinical Significance	The Phase III MANEUVER study demonstrated a substantially higher objective response rate than placebo at Week 25.
Regulatory Clarification	This is a new marketing approval rather than an orphan designation, Fast Track designation or breakthrough therapy designation.
Key Takeaway	Pimjetmi received FDA approval for symptomatic TGCT with a 56% reported objective response rate in its pivotal study.
What to Watch	Treatment adoption, liver safety monitoring, long-term efficacy, quality-of-life outcomes and reimbursement access.
Primary Source	US Food and Drug Administration
Primary Source URL	https://www.fda.gov/drugs/cancer-approvals/fda-approves-pimicotinib-symptomatic-tenosynovial-giant-cell-tumor
Relevant Date	10 November 2026

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