FDA Approves Pimicotinib on November 10 for Symptomatic Tenosynovial Giant Cell Tumor: Overall Response Rate 56 Percent Versus 3.2 Percent at Week 25 in MANEUVER
On November 10, 2026, the Food and Drug Administration approved pimicotinib (Pimjetmi, EMD Serono, Inc.), a kinase inhibitor, for adults with symptomatic tenosynovial giant cell tumor for which surgical resection may cause worsening functional limitation or severe morbidity, according to the agency approval page posted that day.
Efficacy was evaluated in MANEUVER (NCT05804045), a double-blind, randomized 2 to 1, placebo-controlled international trial in patients with confirmed symptomatic disease with measurable disease and at least one lesion of at least 2 cm. Patients received pimicotinib 50 mg or placebo once daily, with randomization stratified by geographic region, China versus non-China.
The major efficacy outcome was overall response rate by blinded independent central review per RECIST v1.1 at Week 25. The rate was 56 percent in the pimicotinib arm and 3.2 percent in the placebo arm. Median duration of response was not reached in the pimicotinib arm; 32 responders, or 91 percent, had a duration of at least 6 months and 27, or 77 percent, had at least 12 months. The agency said statistically significant improvements were also seen at Week 25 in active range of motion, worst pain and physical functioning endpoints.
The agency listed the most common adverse reactions, above 20 percent, as pruritus, rash, face edema, periorbital edema, fatigue, nausea, headache and peripheral edema. The most common laboratory abnormalities, above 30 percent, included increased creatine phosphokinase, lactate dehydrogenase, aspartate aminotransferase, lipase, cholesterol, amylase and alanine aminotransferase. The prescribing information includes warnings for hepatotoxicity, embryo-fetal toxicity and increased serum creatinine without affecting renal function. The recommended dosage is 50 mg orally once daily with or without food.
The review was conducted under Project Orbis of the FDA Oncology Center of Excellence, in collaboration with regulators in Australia, Canada, Israel, Switzerland and the United Kingdom, with the European Medicines Agency as an observer. The drug received fast track and breakthrough therapy designations. This report covers only the facts and resource information on the agency approval page and makes no individual treatment recommendation. Full prescribing information will be posted on Drugs@FDA.
来源链接： https://www.fda.gov/drugs/cancer-approvals/fda-approves-pimicotinib-symptomatic-tenosynovial-giant-cell-tumor
Published by GSM · USA (original Chinese edition)
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