FDA接受Pimicotinib NDA的稀有合并肿瘤, FDA accepts pimicotinib NDA for rare joint tumor, based on positive trial results.

美国食品和药物管理局已批准阿比斯科治疗公司新药申请, 药物是每天服用一次的口服药物皮米科提尼, 用于治疗关节巨细胞瘤, The FDA has accepted Abbisko Therapeutics’ New Drug Application for pimicotinib, a once-daily oral drug, for treating tenosynovial giant cell tumor, a rare joint tumor. 该决定是在第三阶段MANEVER试验取得积极成果之后作出的,结果显示,与安慰剂相比,肿瘤反应、联合流动性、减轻疼痛和身体功能有所改善,受益时间持续14.3个月以上。 The decision follows positive results from the Phase III MANEUVER trial, showing improved tumor response, joint mobility, pain relief, and physical function compared to placebo, with benefits sustained over 14.3 months. Pimicotinib,一种CSF-1R抑制剂,已在中国获得批准,在全球向Merck KGaA颁发许可证。 Pimicotinib, a CSF-1R inhibitor, is already approved in China and is licensed globally to Merck KGaA. 其潜在的美国批准将为替代品有限的病人提供一种非外科治疗选择。 Its potential U.S. approval would provide a non-surgical treatment option for patients with limited alternatives.