New oral option for TGCT when surgery poses risks

The FDA approved a once-daily oral treatment for adults with symptomatic tenosynovial giant cell tumor.

By
Teraya Smith
November 10, 2026
2 min

MDSpire News

Objective:

The article reports the FDA approval of pimicotinib for adults with symptomatic TGCT when surgery may worsen functional limitations or cause severe morbidity, and summarizes the supporting MANEUVER trial and safety information.

Approach:

Approval: The FDA approved pimicotinib (Pimjetmi) on November 10, 2026, for the specified adult TGCT population.
Trial: Approval was supported by MANEUVER (NCT05804045), an international, randomized, double-blind, placebo-controlled trial. Participants with measurable symptomatic TGCT, including at least one lesion 2 cm or larger, were assigned 2:1 to oral pimicotinib 50 mg onc…
Dose and review: The recommended dose is 50 mg orally once daily, with or without food. The FDA reviewed the application through Project Orbis and used its Assessment Aid program.

Key Findings:

The FDA identified pruritus, rash, facial and periorbital edema, fatigue, nausea, headache, and peripheral edema as adverse reactions occurring in more than 20% of patients.
Laboratory abnormalities occurring in more than 30% included elevated creatine phosphokinase, lactate dehydrogenase, aspartate aminotransferase, lipase, cholesterol, amylase, and alanine aminotransferase.
Prescribing information warns about hepatotoxicity, embryo-fetal toxicity, and increased serum creatinine without an associated effect on renal function.