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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