FDA Approves Pimjetmi for Tenosynovial Giant Cell Tumor at 50 mg Once Daily
WASHINGTON — The U.S. Food and Drug Administration (FDA) on November 10 approved pimicotinib (Pimjetmi, EMD Serono, Inc.), a kinase inhibitor, for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity.
Efficacy was evaluated in MANEUVER (NCT05804045), a double-blind, randomized (2:1), placebo-controlled international trial in patients with a confirmed diagnosis of symptomatic TGCT with measurable disease, at least one lesion of at least 2 cm, and for whom surgical resection may cause dysfunction or serious complications. Patients were randomized, stratified by geographic region (China versus non-China), to pimicotinib 50 mg or placebo once daily.
The recommended dosage is 50 mg orally once daily, with or without food. Pimicotinib had received fast track and breakthrough therapy designations.
The most common adverse reactions (more than 20 percent) were pruritus, rash, face edema, periorbital edema, fatigue, nausea, headache, and peripheral edema. The most common laboratory abnormalities (more than 30 percent) were increased creatine phosphokinase, lactate dehydrogenase, aspartate aminotransferase, lipase, cholesterol, amylase, and alanine aminotransferase. The prescribing information includes warnings and precautions for hepatotoxicity, embryo-fetal toxicity, and increased serum creatinine without affecting renal function.
The review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence, in collaboration with the Australian Therapeutic Goods Administration, Health Canada, Israel's Ministry of Health, Switzerland's Swissmedic, and the United Kingdom's Medicines and Healthcare products Regulatory Agency, with the European Medicines Agency as an official observer. The review also used the Assessment Aid, a voluntary submission from the applicant. (Source: U.S. Food and Drug Administration)
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
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